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BACKGROUND: Type 2 diabetes (T2D) is a chronic metabolic disorder that has a notable influence on mental well-being, contributing to elevated morbidity and mortality rates. Depression and anxiety disorders are the most common mental health concerns among patients with T2D worldwide. Therefore, the present study aimed to assess the impact of an online intensive lifestyle intervention (ILI) on mental health outcomes (depression and anxiety) in patients with T2D in India. MATERIALS AND METHODS: This retrospective pre-post analysis included adult patients (aged > 18 years) diagnosed with T2D who were enrolled in a diabetes management program in India between June 2021 and June 2023. The intervention consisted of lifestyle modifications such as a customized plant-based diet, regular physical activity, psychological support through group and individual therapy, and medical management. Data were extracted from the electronic database of the clinic, including anthropometry, medical history, biochemical parameters, symptoms of depression, and anxiety (assessed using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorders-7 (GAD-7) scale) at the start and end of the six-month intervention period. RESULTS: Of the 1061 eligible patients (177 with prediabetes), 40.3% were female. The mean age, duration of diabetes, and HbA1c levels were 52 ± 10.4 years, 9.8 ± 7.8 years, and 8 ± 1.7%, respectively. The prevalence of symptoms of depression and anxiety (ranging from mild to severe) was 46% and 44.3%, respectively, which reduced to 28.7% and 29.2%, respectively, post-intervention. CONCLUSION: Integrated ILI successfully improved the symptoms of anxiety and depression, highlighting the importance of a multidisciplinary approach that includes diet, physical activity, psychological support, and medical management in enhancing mental health outcomes among patients with T2D. Future prospective studies are needed to explore the long-term effects of such interventions and develop effective strategies for promoting mental health in diverse populations. TRIAL REGISTRATION: The study was approved by the Freedom from Diabetes Research Foundation Institutional Ethics Committee (approval number FFDRF/IEC/2024/7) and registered in the Clinical Trials Registry of India (CTRI/2024/03/064596, registered on March 21, 2024).
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Ansiedade , Depressão , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/psicologia , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/complicações , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Depressão/terapia , Índia , Ansiedade/terapia , Ansiedade/psicologia , Adulto , Exercício Físico/psicologia , Estilo de Vida , Transtornos de Ansiedade/terapia , IdosoRESUMO
Identification of novel subgroups of type 2 diabetes (T2D) has helped improve its management. Most classification techniques focus on clustering or subphenotyping but not on both. This study aimed to compare both these methods and examine the rate of T2D remission in these subgroups in the Indian population. K-means clustering (using age at onset, HbA1C, BMI, HOMA2 IR and HOMA2%B) and subphenotyping (using homeostatic model assessment (HOMA) estimates) analysis was done on the baseline data of 281 patients with recently diagnosed T2D who participated in a 1-year online diabetes management program. Cluster analysis revealed three distinct clusters: severe insulin-deficient diabetes (SIDD), severe insulin-resistant diabetes (SIRD), and mild obesity-related diabetes (MOD) while subphenotyping showed four distinct categories: hyperinsulinemic, insulinopenic, classical, and nascent T2D. Comparison of the two approaches revealed that the clusters aligned with phenotypes based on shared characteristics of insulin sensitivity (IS) and beta cell function (BCF). Clustering correctly identified individuals in nascent group (high IS and BCF) as having mild obesity related diabetes which subphenotyping did not. Post-one-year intervention, higher remission rates were observed in the MOD cluster (p = 0.383) and the nascent phenotype showing high IS and BCF (p = 0.061, Chi-Square test). In conclusion, clustering based on a comprehensive set of parameters appears to be a superior method for classifying T2D compared with pathophysiological subphenotyping. Personalized interventions may be highly effective for newly diagnosed individuals with high IS and BCF and may result in higher remission rates in these individuals. Further large-scale studies are required to validate these findings.
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Diabetes Mellitus Tipo 2 , Resistência à Insulina , Fenótipo , Humanos , Masculino , Feminino , Índia/epidemiologia , Pessoa de Meia-Idade , Adulto , Análise por Conglomerados , Indução de Remissão , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/metabolismo , Índice de Massa CorporalRESUMO
Background The increasing incidence of type 2 diabetes (T2D) in India underscores the pressing need for effective management strategies. Meeting the American Diabetes Association (ADA) ABC targets for diabetes (glycated hemoglobin (HbA1c), blood pressure, and serum low-density lipoprotein cholesterol (LDL-C)) is crucial for effectively managing T2D, as it reflects the optimal control of key metabolic parameters. Insulin resistance (IR) and impaired beta cell function (BCF) have been found to have a significant impact on glycemic control, lipid metabolism, and hypertension, contributing to the complex cardiovascular risk profile of patients with T2D. This study aimed to explore the association between ABC targets for diabetes, IR, BCF, and dyslipidemia in a cross-sectional cohort of T2D patients. Methods This retrospective study examined data from 681 T2D patients with comorbid hypertension and dyslipidemia. The patients were part of a one-year online lifestyle intervention program for diabetes management at the Freedom from Diabetes Clinic in Pune, India, between January 2021 and December 2022. Baseline data (at the time of enrollment in the program) on medical history and anthropometric and biochemical parameters were retrospectively extracted from medical records and used to assess ABC targets and other clinical parameters. The ABC targets for diabetes include three goals: an HbA1c level of less than 7.0%, a blood pressure level of less than 140/90 mmHg, and an LDL-C level of less than 100 mg/dL. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Homeostatic Model Assessment of Beta Cell Function (HOMA-B), and Quantitative Insulin Sensitivity Check Index (QUICKI) were calculated using standard formulas. Results Cross-sectional analysis at baseline showed that 152 (22.3%) participants met all three ABC targets, 306 (45.0%) and 183 (26.8%) participants met two or one targets, respectively, and 40 (5.9%) did not meet any of the ABC targets. Participants meeting all three targets showed significantly lower IR, higher sensitivity (HOMA-IR, median 2.1; QUICKI, median 0.34), higher BCF (HOMA-B, median 62.9), and healthier lipid profiles (mg/dL) (total cholesterol, median 126; triglycerides, median 114; and non-high-density lipoprotein (HDL), median 84) than those who did not meet any of the ABC targets (HOMA-IR, median 3.4; QUICKI, median 0.31; HOMA-B, median 31.7; total cholesterol, median 221; triglycerides, median 187; and non-HDL, median 182) (p < 0.01). A significant association was observed between lower BMI (< 25 kg/m2), lower IR (HOMA-IR <2.5), and meeting all three ABC targets (p < 0.01). No significant association was observed between the duration of diabetes and ABC target status (p > 0.1). Lower IR was identified as a predictor of achievement of all three ABC targets (p < 0.01). Conclusion This study highlights the significance of meeting ABC targets for diabetes in relation to not only a better lipid profile but also lower IR and higher BCF. These preliminary findings provide novel insights into the interplay between IR, BCF, dyslipidemia, and meeting ABC targets in an Indian T2D population. These findings highlight the need for effective diabetes management strategies and improved patient outcomes, considering factors such as BMI and IR indices.
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BACKGROUND: The global rise in diabetes, particularly in India, poses a significant public health challenge, with factors such as limited awareness, financial strain, and cultural considerations hindering its effective management. Although lifestyle changes have shown promising results, their consistent implementation and maintenance continue to pose challenges. Most studies have focused primarily on dietary modifications, overlooking other essential aspects of lifestyle intervention. The DiRemI study aims to address these gaps by evaluating the efficacy of a comprehensive one-year program that combines diet, exercise, psychological support, and medical management to achieve weight loss, diabetes remission, and improved glycemic control among patients with type 2 diabetes (T2D) in India, while also considering the unique needs of the Indian population. METHODS: The DiRemI study is a prospective, open-label, matched-group trial aimed at assessing the impact of a one-year online integrated intensive lifestyle intervention (ILI) comprising dietary modifications, physical activity, psychological support, and medical management on weight loss and remission in adult T2D patients (aged 30-70 years), with a body mass index (BMI) between 25 and 35 kg/m2, and disease duration of <15 years. ILI will be compared with routine medical care (RMC). Participants will be recruited from three clinics: one providing ILI and two others providing RMC. The co-primary outcome will be weight loss and remission at 12 months, with a follow-up at 18 months. The proposed sample size is 360 participants (180 each in intervention and control group). DISCUSSION: The DiRemI study represents the first large-scale remission study in India to show the effectiveness of an integrated approach in the remission and management of T2D and its complications. The findings of this study hold the potential to report evidence-based strategies for managing T2D both in India and globally, thus alleviating the substantial burden of diabetes on public health systems. TRIAL REGISTRATION: Clinical Trials Registry, India (Registered Number: CTRI/2023/06/053885).
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/psicologia , Índia , Estudos Prospectivos , Pessoa de Meia-Idade , Adulto , Feminino , Masculino , Idoso , Redução de Peso , Exercício Físico , Estilo de Vida , Indução de Remissão , Índice de Massa CorporalRESUMO
Achieving diabetes remission (HbA1c<48mmol/mol without the use of anti-diabetic medication for 3 months) might not assure restoration of a normal glycemic profile [fasting blood sugar level <5.6 mmol/L and Post-Prandial (PP) blood glucose <7.8mmol/L]. The study investigates the factors associated with OGTT clearance in patients under type 2 diabetes remission. Four hundred participants who achieved remission during a one-year online structured lifestyle modification program, which included a plant-based diet, physical activity, psychological support, and medical management (between January 2021 and June 2022), and appeared for the OGTT were included in the study. OGTT clearance was defined by fasting blood glucose < 5.6 mmol/L and 2-hour post-prandial blood glucose <7.8 mmol/L post-consumption of 75g glucose solution. Of the 400 participants, 207 (52%) cleared OGTT and 175 (44%) had impaired glucose tolerance (IGT). A shorter diabetes duration (<5 years) was significantly associated with OGTT clearance (p<0.05). Pre-intervention use of glucose-lowering drugs showed no association with OGTT clearance (p<0.1). Post-intervention, the OGTT-cleared group showed significantly higher weight loss (p<0.05) and a decrease in HbA1c compared to the IGT group (p<0.05). Improvement in Insulin resistance and ß-cell function was also higher in the OGTT-cleared group compared to the IGT group (p<0.05). In conclusion, clearing the OGTT is a possibility for those achieving remission through lifestyle interventions. Higher weight loss, a shorter duration of diabetes, and improvement in insulin resistance were significantly associated with OGTT clearance in participants in remission. Future randomized controlled trials with longer follow-ups may help substantiate our findings.
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Glicemia , Diabetes Mellitus Tipo 2 , Teste de Tolerância a Glucose , Estilo de Vida , Humanos , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/sangue , Masculino , Feminino , Pessoa de Meia-Idade , Glicemia/metabolismo , Glicemia/análise , Idoso , Indução de Remissão , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/metabolismo , Intolerância à Glucose/terapia , Exercício Físico , AdultoRESUMO
Remission is often considered the ultimate goal in Type 2 Diabetes (T2D) management and care. Although metabolic surgery is the conventional choice to achieve remission, substantial evidence suggests the possibility of T2D remission through lifestyle interventions. In this context, the current perspective explores recent scientific advancements in lifestyle intervention for diabetes remission and also emphasises its clinical applicability as a pragmatic approach to diabetes management. The perspective further provides additional evidence on remission from the authors' own research findings in the Indian population. We propose that a holistic lifestyle intervention approach - individualised diet plan, exercise protocol, and psychological intervention - may be a benchmark protocol to achieve T2D remission.
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Type 2 diabetes (T2D) remission is being widely accepted and documented as feasible through calorie restriction and bariatric surgery. Recent studies with lifestyle changes have also shown T2D remission; however, long-term remission through lifestyle modifications is not yet established. Though glycated hemoglobin (HbA1c) is a universally accepted indicator of glycemic status, oral glucose tolerance test (OGTT) would be a more robust marker in understanding whether the metabolic abnormalities in glucose metabolism have undergone complete remission as well. We present a case series of four patients enrolled in the Holistic Transformation Program, a lifestyle modification program, between 2016 and 2018. The intervention was a combination of a vegan diet, structured exercises, and stress management delivered over 12 months. All four patients successfully achieved T2D remission and cleared OGTT consecutively for a minimum period of 3 years. Our findings suggest that long-term T2D remission may be possible through lifestyle modification.
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An elderly obese male patient (60 yrs.) diagnosed Type 2 Diabetes (T2D) presented to our clinic. He was on 94 units of insulin and oral hypoglycemic agents during his initial consultation visit. After obtaining informed consent, he was enrolled into intense lifestyle modification program for a duration of six months, with a three-year follow-up after the intervention. The patient underwent complete remission losing 13 kg of body weight and also successfully clearing oral glucose tolerance tests (OGTT) for three consecutive years. We present three unique features in the current case report: (1) Elderly age of the patient (2) OGTT clearance along with normalisation of HbA1c, and (3) High initial insulin dosage at baseline. A few of the common positive predictors of T2D remission documented in earlier studies include younger age and minimal or low doses of insulin. The current case study shows that older age and higher dosage of insulin, it is possible to undergo complete T2D remission along with OGTT clearance through intense holistic lifestyle modification. Future experimental studies with adequate sample sizes would help substantiate our observation.