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BACKGROUND: Metabolomics profiling is an objective assessment of metabolic responses to intricate dietary patterns. However, few studies have investigated the potential benefits associated with personalized behavioral nutrition (PBN) interventions incorporating the metabolomics approach for improving diabetes outcomes for older Asian Americans with Type 2 diabetes. OBJECTIVE: This article describes the protocol for a pilot study testing self-management of a nutrition intervention-provided personalized dietary advice incorporating metabolites phenotypic feedback and digital self-monitoring of diet and blood glucose. METHODS: A total of 60 older Asian Americans will be randomized into two groups: a PBN group and a control group. Participants in the PBN group will receive personalized dietary advice based on dietary and phenotypic feedback-used metabolic profiles. This study aims to examine the feasibility and preliminary effects of the PBN on diabetes outcomes. RESULTS: The study began in September 2020, with estimated complete data collection by late 2021. DISCUSSION: Findings from this pilot study will inform future research for developing personalized nutrition interventions for people with Type 2 diabetes.
Subject(s)
Asian/psychology , Diabetes Mellitus, Type 2/diet therapy , Diet , Disease Management , Health Behavior , Aged , Asian/statistics & numerical data , Blood Glucose/analysis , Female , Humans , Male , Pilot Projects , Surveys and QuestionnairesABSTRACT
Type 2 diabetes (T2D) contributes to reduced quality of life in older adults, especially in those with comorbidities such as being overweight or obese. Personal fitness technology (Fitbit ®) has the potential to improve the management of T2D. Using a semi-structured interview guide, focus groups were conducted to explore participants' acceptability and experiences following a behavioral lifestyle intervention that integrated Fitbit in overweight/obese older adults with T2D amid the COVID-19 pandemic which began during the time of this study. Focus group transcripts were transcribed and analyzed using thematic analysis. Eighteen (18) of the 20 participants completed the program and focus group interviews. Overall, we observed high acceptability of the program, and participants reported favorable experiences such as increased knowledge of health behaviors, improved diabetes management, and improved quality of life following the behavioral lifestyle intervention, even under stressful life circumstances from COVID-19.
Subject(s)
Behavior Therapy , COVID-19/epidemiology , Diabetes Mellitus, Type 2/psychology , Fitness Trackers , Life Style , Obesity/psychology , Aged , Diabetes Mellitus, Type 2/complications , Female , Focus Groups , Health Behavior , Humans , Male , Obesity/etiology , Obesity/therapy , Patient Acceptance of Health Care , Patient Satisfaction , Quality of LifeABSTRACT
Over one quarter of older adults in the U.S. has diabetes; and, physical activity is important for the promotion of healthy aging in this population. The purpose of this clinical demonstration project is to evaluate the effect of physical activity in the form of walking on glycemic control and timed gait in older Veterans with type 2 diabetes (T2D). Veterans aged ≥60 years were enrolled in the Geriatrics Walking Clinic (GWC), a clinical demonstration project, at South Texas Veterans Health Care System. GWC is a 6-week clinical program that promotes physical activity and is delivered by a registered nurse/diabetes educator and geriatrician. Veterans were recruited from the VA clinics. Enrolled patients received a pedometer at an initial face-to-face visit, were followed with weekly phone calls to monitor steps/day, received encouragement, and participated in a final face-to-face visit at the end of 6 weeks. In a sub-set of patients with T2D, we performed a chart review and recorded Hemoglobin A1c (HbA1c) at 3, 6, and 12 months after completion of the program. Timed Gait, a major characteristic of frailty, was measured at baseline and after completing the program. Change in HbA1c and timed gait compared to baseline was examined using paired t-tests. Sixty-two patients had HbA1c values available and were included in this analysis. Of these, 36, 52, and 61 patients had repeat HbA1c at 3, 6, and 12 months after the intervention, respectively. Mean age was 68 ± 6 years, 58% were Hispanic, and 92% males. HbA1c improved at 3 months (-0.49, 95% CI: -0.87 to -0.12, p=0.013), at 6 months (-0.40, 95% CI: -0.68 to -0.12, p=0.006), and at 12 months (-0.30, 95% CI: -0.57 to -0.029, p=0.031) compared to baseline. Timed Gait also improved (9.3 ±1.7 vs. 10.2 ±1.8, p<0.001). The finding highlights that older patients with T2D benefit from a GWC with improved glycemic control and timed gait.
Subject(s)
Diabetes Mellitus, Type 2 , Geriatrics , Veterans , Aged , Diabetes Mellitus, Type 2/therapy , Female , Gait , Glycated Hemoglobin/analysis , Humans , Male , WalkingABSTRACT
BACKGROUND: South Asians (SAs) have a well-documented risk for mortality related to coronary artery disease (CAD). However, there is a lack of evidence to guide the implementation and dissemination of primary and secondary interventions to control and deter progression of CAD in SAs. OBJECTIVE: The aim of this study is to explore and describe self-regulation behaviors in SAs with CAD using Leventhal's Common Sense Model. METHODS: In this mixed-methods study, quantitative data were collected using 3 survey questionnaires (demographics, Illness Perception Questionnaire-Revised, and Coping/Self-Regulation Behaviors). Before completing the surveys, a subset of the sample (n = 20) participated in individual face-to-face or telephone interviews. RESULTS: A total of 102 SAs were enrolled (age, 53.5 ± 9.98 years). On average, participants rated themselves high (63 ± 3.06) on negative perceptions. In addition, they discussed desi diet, stress, a lack of physical activity, ignoring symptoms, and kismet (fate) as the most important perceived causes of their CAD. Most of the participants modified their lifestyle after their CAD event. Participants expressed regret for not having changed their lifestyle earlier when they were experiencing early symptoms of their CAD. CONCLUSION: Findings from this study enhance the understanding of self-regulation behaviors of SAs with CAD. Ultimately, these findings will inform the development and implementation of targeted interventions that address culture-specific lifestyle modification for SAs with CAD.
Subject(s)
Asian/psychology , Coronary Artery Disease/psychology , Coronary Artery Disease/therapy , Health Behavior/ethnology , Life Style/ethnology , Adult , Asia, Western/ethnology , Coronary Artery Disease/ethnology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Socioeconomic Factors , Surveys and Questionnaires , TexasABSTRACT
OBJECTIVE: This study investigates the effects of a behavioral lifestyle intervention on inflammatory cytokines and frailty in older adults (≥ 65 years) with type 2 diabetes (T2D). METHOD: We conducted a single-arm, 6-month intervention supplemented with diet and activity self-monitoring technology. We assessed frailty using Fried criteria and quantified inflammatory cytokines (interleukin [IL]-2, IL-4, IL-6, IL-8, IL-10, granulocyte-macrophage colony-stimulating-factor [GM-CSF], interferon [IFN-γ], tumor necrosis factor [TNF-α]) using a multiplex assay. We used paired t-tests with significance at P < .05. We calculated the Spearman correlation and evaluated the relationship between frailty, BMI, and inflammatory cytokines. RESULTS: Eighteen participants completed the study (mean ± SD: 71.5 ± 5.3 years; BMI: 34 ± 6 kg/m2). At baseline, we had 4 frail, 13 pre-frail, and 1 non-frail participant. At 6 months, we observed the therapeutic effects of the intervention on frailty score, BMI, IL-2, IFN-y, and GM-CSF. DISCUSSION: The study highlights the importance of behavioral lifestyle intervention in improving inflammatory cytokines and frailty in older adults.
Subject(s)
Diabetes Mellitus, Type 2 , Frailty , Humans , Aged , Cytokines/pharmacology , Granulocyte-Macrophage Colony-Stimulating Factor/pharmacology , Diabetes Mellitus, Type 2/therapy , Feasibility Studies , Tumor Necrosis Factor-alpha/pharmacology , Life StyleABSTRACT
BACKGROUND: Fatigue is a strong predictor of negative health outcomes in older adults. Kynurenine, a metabolite of tryptophan, is strongly associated with fatigue. Reductions in fatigue are observed with exercise; however, exercise training does not completely alleviate symptoms. Branched-chain amino acids (BCAAs) have been shown to have advantageous effects on exercise performance and compete with kynurenine for transport into the central nervous system. Thus, the combination of BCAA and exercise may exert synergized effects of mental and physical fatigue. Therefore, we hypothesize that BCAA added to exercise will shift kynurenine metabolism toward enhanced synthesis of kynurenic acid, thereby reducing fatigue. OBJECTIVE: This randomized, double-blind, placebo-controlled trial aims to compare the effects of acute (approximately 45 min) and chronic (8 wk) exercise with and without BCAA supplementation on mental and physical fatigue and assess whether the hypothesized outcomes are modulated by changes in kynurenine metabolism in 30 older adults (n=15, 50% per group). METHODS: Older adults (aged 60-80 y) who do not exercise >2 days per week and self-report fatigue (≥3 on a scale of 1-10) will be recruited. Participants will be randomized to either the exercise+BCAA group or exercise+placebo group. Participants will engage in high-volume, moderate-intensity, whole-body exercise training (aerobic and resistance exercise; either in-person or web-based sessions) 3 times per week for 8 weeks. In addition, participants will consume daily either 100 mg/kg body weight of BCAA (2:1:1 leucine:isoleucine:valine) or placebo (maltodextrin) throughout the 8-week intervention. BCAA and placebo powders will be identical in color and dissolved in 400 mL of water and 2.5 g of a calorie-free water flavor enhancer. Muscle biopsies will be collected before and after the intervention after a 12-hour fast to examine changes in the biomarkers of tryptophan metabolism and inflammation. Our primary outcomes include changes in mental and physical fatigue and metabolism after the 8-week exercise training between the 2 groups. Mental and physical fatigue will be measured before and after the intervention. Mental fatigue will be subjectively assessed through the completion of validated questionnaires. Physical fatigue will be measured by isometric handgrip, 1-repetition maximum, chair rise, 400-meter walk, and cardiopulmonary exercise tests. RESULTS: The study was funded in March 2022, with an anticipated projected data collection period lasting from January 2023 through December 2023. CONCLUSIONS: The discovery that kynurenine concentrations are associated with fatigue and are responsive to BCAA supplementation during exercise training could have important implications for the development of future interventions, both lifestyle and pharmacologic, to treat fatigue in older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT05484661; https://www.clinicaltrials.gov/study/NCT05484661. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52199.
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Background: Illness perceptions are individual beliefs or experiences about the nature and treatment of their illness. Although extensive research exists about illness perceptions, little is known about illness perceptions of multimorbidity. Methods: The purpose of this parallel-convergent mixed-methods study was to comprehensively explore illness perception of multimorbidity among community dwelling older adults. Data was collected using one-on-one semi-structured interviews (n=17) and the Multimorbidity Illness Perception Scale (MULTIPleS) (n=116). Qualitative data were analyzed using content analysis while quantitative data were analyzed with descriptive and inferential statistics. Both qualitative and quantitative findings were integrated to identify differences in illness perceptions of multimorbidity by participant's socio-demographic and illness-related characteristics. Results: Overall, participants were mostly female (71%), self-reported as Hispanic (35%), Black (33%), White (27%), or Asian (5%). From the content analysis of the qualitative data, we described three themes pertaining to Illness perception of multimorbidity which were influenced by both participants' socio-demographic and illness-related characteristics: (1) inter-relationships between conditions (2) consequences and priorities and (3) impact of multimorbidity on wellbeing. While inferential analysis of quantitative data indicated statistically significant differences across only socio-demographic characteristics such as race/ethnicity (causal links, prioritization, summary scale) and educational attainment (prioritization subscale). Mixed analysis of qualitative and quantitative findings confirmed that illness perception of multimorbidity may not differ by the number of chronic conditions. Conclusions: Illness perception of multimorbidity may not differ by the number of chronic conditions the participants had. Rather, participants prioritized the impact of multimorbidity on their overall wellbeing, placing less importance on the number of their chronic conditions. Additional studies are needed to further characterize illness perceptions of multimorbidity and develop interventions that extend beyond disease-focused interventions to address holistic needs of older adults with multimorbidity.
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BACKGROUND: The majority of older veterans do not meet the minimum healthy diet or physical activity recommendations despite known benefits. Identifying ways to increase adherence to programs that improve dietary quality and physical activity may reduce the risk of disability in older veterans. Peer-based interventions may be one method for facilitating lasting behavior change because peers often share a common culture and knowledge regarding problems their community experiences. OBJECTIVE: This study aims to develop, pilot, and evaluate a theory-driven, 12-week, peer-led nutrition and exercise intervention that targets older veterans with dysmobility and assess its feasibility in 2 diverse urban areas with underrepresented populations. METHODS: Community-dwelling veterans aged >65 years with self-reported dysmobility (defined as difficulty in at least 1 of the following: walking quickly across a street, walking a mile, ascending a flight of stairs, rising from a chair without the use of arms, or a fear of falling) from 2 Department of Veterans Affairs Geriatric Research, Education, and Clinic Centers (Baltimore, Maryland, and San Antonio, Texas) will be eligible to participate. First, this study will use validated mixed methods via web-based surveys (n=50 per site) to assess potential physical, social or environmental, and behavioral or lifestyle barriers that affect physical activity and dietary quality (phase 1). Next, we will use knowledge gained from these assessments and feedback from a focus group (n=10 per site) to adapt established Department of Veterans Affairs diet and exercise program materials to develop peer-led intervention materials and train peer leaders (n=3 per site). Finally, we will determine the feasibility and acceptability of the intervention to assess reach (recruitment and retention), adoption (satisfaction, perceived utility, attendance, and engagement), and implementation (fidelity of intervention), as well as the estimated magnitude and potential impact on selected outcomes (ie, diet quality and mobility) in 20 older veterans with dysmobility (n=10 per site). RESULTS: The study was funded on January 1, 2022, with a projected data collection period of June 1, 2022, to December 31, 2023. CONCLUSIONS: This study offers an innovative approach to identifying strategies that increase long-term adherence to lifestyle modification programs that improve dietary quality and physical activity in older veterans with dysmobility. TRIAL REGISTRATION: ClinicalTrials.gov NCT04994938; https://clinicaltrials.gov/ct2/show/NCT04994938. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39192.
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PURPOSE OF REVIEW: This review evaluated recent randomized controlled trials (RCTs) examining the chronic intake of whole foods associated with the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), Mediterranean-DASH Intervention for Neurogenerative Delay (MIND), and ketogenic (KETO) diets on cognitive function. RECENT FINDINGS: We identified RCTs related to olive oil (N = 3), nuts (N = 7), fatty fish (N = 1), lean meats (N = 4), fruits and vegetables (N = 9), legumes (N = 1), and low-fat dairy (N = 4), with 26/29 reporting positive results on at least one measure of cognition. We also identified 6 RCTs related to whole food-induced KETO diets, with half reporting positive effects on cognition. Variations in study design (i.e., generally the studies are < 6 months and include middle-aged and older, cognitively intact participants) and small sample sizes make it difficult to draw conclusions across studies; however, the current evidence from RCTs generally supports individual component intakes of these dietary patterns as an effective, nonpharmacological approach to improve cognitive health in adults.
Subject(s)
Diet, Mediterranean , Dietary Approaches To Stop Hypertension , Aged , Cognition , Eating , Humans , Middle Aged , Randomized Controlled Trials as Topic , VegetablesABSTRACT
Examine the association between glycemic control and cognition. Included subjects ≥60 years who participated in the 2013 to 2014 National Health and Nutrition Examination Survey and completed one of the followings: Consortium to Establish a Registry for Alzheimer's Disease Word List (CERAD-WL), Animal Fluency (AF), Digit Symbol Substitution Test (DSST), and CERAD-Delayed Recall (CERAD-DR). Stratified participants into: No type 2 diabetes (T2D; N = 557), Controlled T2D (N = 41), Uncontrolled T2D (N = 120), and Untreated T2D (N = 86). Multiple regression was used to examine the association between variables. After adjusting for demographics and cardiovascular risk factors, Uncontrolled T2D was associated with lower DSST (ß = -3.164, p = .04), and Untreated T2D was associated with a trend for having lower CERAD-DR (ß = -.496, p = .06) scores. T2D, independent of glycemic control, is associated with cognitive impairment and this relationship is influenced by modifiable and non-modifiable risk factors.
Subject(s)
Cognitive Dysfunction , Diabetes Mellitus, Type 2 , Cognition , Diabetes Mellitus, Type 2/complications , Glycemic Control , Humans , Nutrition SurveysABSTRACT
BACKGROUND: In breast cancer survivors, chemotherapy-induced muscle loss has been shown to be attenuated with structured resistance exercise. Creatine supplementation can increase bioenergetics in skeletal muscle, which helps to improve overall strength and endurance and reduce muscular fatigue. Therefore, we hypothesize that adding creatinine supplementation to exercise training will accelerate improvements in strength, endurance, and bioenergetics in breast cancer survivors. OBJECTIVE: The primary objective is to determine the effects of combining creatine supplementation with exercise on modulating strength and physical function in breast cancer survivors by comparing these effects to those of exercise alone. The secondary objectives are to determine if creatine supplementation and exercise can increase the intramuscular storage of creatine and improve body composition by comparing this intervention to exercise alone. METHODS: We aim to test our hypothesis by conducting an open-label randomized controlled trial of 30 breast cancer survivors who have completed chemotherapy within 6 months of enrollment. Eligible participants will be equally randomized (1:1) to either a creatine and exercise group or an exercise-only group for this 12-week intervention. Individuals who are randomized to receive creatine will be initially dosed at 20 g per day for 7 days to boost the availability of creatine systemically. Thereafter, the dose will be reduced to 5 g per day for maintenance throughout the duration of the 12-week protocol. All participants will engage in 3 center-based exercise sessions, which will involve completing 3 sets of 8 to 12 repetitions on chest press, leg press, seated row, shoulder press, leg extension, and leg curl machines. The primary outcomes will include changes in strength, body composition, and physical function in breast cancer survivors. The secondary outcomes will be intramuscular concentrations of creatine and adenosine triphosphate in the vastus lateralis, midthigh cross-sectional area, and quality of life. RESULTS: As of October 2021, a total of 9 patients have been enrolled into the study. No unexpected adverse events have been reported. CONCLUSIONS: Creatine is being studied as a potential agent for improving strength, endurance, and bioenergetics in breast cancer survivors following chemotherapy. The findings from our trial may have future implications for supporting breast cancer survivors in reversing the muscle loss experienced during chemotherapy and improving their physical function and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT04207359; https://clinicaltrials.gov/ct2/show/NCT04207359. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/26827.
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BACKGROUND: Self-monitoring is key to successful behavior change in diabetes and obesity, and the use of traditional paper-based methods of self-monitoring may be time-consuming and burdensome. OBJECTIVE: This study aimed to explore participant experiences while using technology-assisted self-monitoring of lifestyle behaviors and health indicators among overweight or obese adults with type 2 diabetes. METHODS: Qualitative data collected from the intervention group of a 6-month, three-arm (control, paper diary, and technology-assisted self-monitoring groups) randomized clinical trial were analyzed. Study participants in the intervention group monitored their diet, exercise, and weight using the LoseIt! app, and their blood glucose levels using a glucometer and the Diabetes Connect app. Semistructured group discussions were conducted at 6 weeks (n=10) from the initiation of the behavioral lifestyle intervention and again at 6 months (n=9). All group interviews were audiotaped and transcribed verbatim. Using a combination of thematic and comparative analysis approaches, two trained professionals coded the transcriptions independently and then discussed and concluded common themes for the 6-week and 6-month discussions separately. RESULTS: The sample (n=10), which primarily involved African American participants (n=7) and female participants (n=8), had a mean age of 59.4 years. The following eight themes emerged: (1) perceived benefits of technology-assisted self-monitoring; (2) perceived ease of use (eg, barriers: technical difficulties and lack of self-discipline; facilitators: help from family, friends, and the program); (3) use of technology-assisted self-monitoring; (4) facilitators of engaging in healthy lifestyle behaviors (eg, visualization and awareness of calorie input/expenditure); (5) positive lifestyle change; (6) barriers of engaging in healthy lifestyle behaviors (eg, event influence); (7) learning curve; and (8) monitored data sharing. The first six of these themes were shared between the 6-week and 6-month timepoints, but the codes within these themes were not all the same and differed slightly between the two timepoints. These differences provide insights into the evolution of participant thoughts and perceptions on using technology for self-monitoring and subsequent behavioral lifestyle changes while participating in lifestyle interventions. The findings from the 6-week and 6-month data helped to paint a picture of participant comfort and the integration of technology and knowledge overtime, and clarified participant attitudes, difficulties, behavioral processes, and modifications, as well as health indicators that were experienced throughout the study. CONCLUSIONS: Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change. These patient perspectives need to be considered in future research studies when investigating the effectiveness of using technology-assisted self-monitoring, as well as in clinical practice when recommending technology-assisted self-monitoring of lifestyle behaviors and health indicators to improve health outcomes.
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BACKGROUND: In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients' perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. OBJECTIVE: This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. METHODS: Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. RESULTS: A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. CONCLUSIONS: Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648.
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BACKGROUND: Frailty is a geriatric syndrome that leads to poor health outcomes with aging. Previous studies have demonstrated that insulin resistance and inflammation predict frailty onset. Metformin is a widely used, well-tolerated drug that improves insulin sensitivity and displays anti-inflammatory properties. It is also known to prevent diabetes onset in adults with prediabetes. We hypothesize that metformin in older adults with prediabetes will promote healthy aging and prevent frailty. Here we describe an ongoing placebo-controlled, double-blinded clinical trial of metformin for the prevention of frailty in older adults with prediabetes. METHODS: Older adults aged more than 65 years are randomized to metformin or placebo and are followed for 2 years. Prediabetes, required for inclusion, is assessed by 2-hour oral glucose tolerance test. Exclusion criteria are baseline frailty (Fried criteria), diabetes, dementia, untreated depression, active malignancy, or severe cardiovascular, pulmonary, and neurologic diseases. Primary outcome is frailty; secondary outcomes are physical function (Short Physical Performance Battery), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (oral glucose tolerance test), and body composition (dual-energy x-ray absorptiometry). Subjects are followed every 3 months for safety assessments and every 6 months for frailty assessment (Fried criteria) and oral glucose tolerance test, and every 12 or 24 months for secondary outcomes. Enrollment of 120 subjects (completers) will take place over a 2-year period. CONCLUSION: Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with prediabetes. Findings from this trial may have future implications for the screening and potential treatment of prediabetes in older patients with metformin for the prevention of frailty.
Subject(s)
Blood Glucose/metabolism , Frailty/prevention & control , Metformin/administration & dosage , Aged , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Double-Blind Method , Female , Follow-Up Studies , Frailty/blood , Frailty/etiology , Glucose Tolerance Test , Humans , Hypoglycemic Agents/administration & dosage , Insulin Resistance/physiology , Male , Prognosis , Time FactorsABSTRACT
PURPOSE: Frailty is a syndrome of vulnerability and physical decline with aging that increases risk for disability, hospitalizations, and death. To date, interventions for frailty have primarily focused on exercise and/or nutritional interventions, many of which show improvement in frailty-related characteristics, such as gait speed and lower extremity strength and function. The goal of this article was to review prior research studies investigating interventions for frailty and review the literature with regard to the role of insulin resistance and inflammation in the development of frailty. Also included is a discussion of potential therapeutic interventions for frailty. METHODS: A literature search was conducted by using PubMed and the search terms frailty, interventions, and older adults. This review focused on larger studies (N ≥ 100 participants) that examined the effect of specific interventions on frailty as a primary outcome or on measures that are closely related to frailty, such as gait speed, muscle strength, and/or sarcopenia. FINDINGS: The results of prior studies of exercise interventions for the frailty syndrome as the primary outcome are mixed, with some but not all showing benefit. However, many exercise interventions have demonstrated improvement in components of frailty, such as strength, gait speed, and physical activity. The evidence shows that regular physical activity is beneficial for frail older adults or those at high risk of frailty and that the adverse effects related to exercise are minimal compared with the potential gains. However, questions remain as to the optimal type and duration of exercise and whether results of clinical trials are easily and feasibly implemented in a clinical setting in individuals whose motivation for exercise may be low. There is now increasing interest in pharmacologic agents that could potentially be useful in the prevention or treatment of frailty, in part based on advances in basic biology of aging research demonstrating that pharmacological agents extend lifespan in rodents. Several studies now show that obesity, insulin resistance, inflammation, and diabetes are associated with and predict frailty. Because metformin targets insulin resistance and inflammation, it is a plausible pharmacologic agent to prevent frailty. A clinical trial is underway to examine metformin's usefulness in frailty prevention. IMPLICATIONS: Although the benefits of exercise are known, adherence to these regimens may be difficult for individual older adults due to lack of motivation, access, or limitations due to chronic medical conditions. Studies are currently underway to examine novel agents for the prevention of frailty in older adults.