Strategies to reduce the onset of sleeve gastrectomy associated bone loss (STRONG BONES): Trial design and methods.

Background: Despite recognized improvements in obesity-related comorbidities, mounting evidence implicates surgical weight loss in the onset of skeletal fragility. Sleeve gastrectomy (SG) is the most commonly performed bariatric procedure and is associated with 3-7% axial bone loss in the year following surgery. Bisphosphonates are FDA-approved medications for the prevention and treatment of age-related bone loss and may represent a strategy to reduce bone loss following SG surgery. Methods: The Strategies to Reduce the Onset of Sleeve Gastrectomy Associated Bone Loss (STRONG BONES) trial (NCT04922333) is designed to definitively test whether monthly administration of the bisphosphonate, risedronate, for six months can effectively counter SG-associated bone loss. Approximately 120 middle-aged and older (≥40 years) SG patients will be randomized to six months of risedronate or placebo treatment, with skeletal outcomes assessed at baseline, six, and 12-months post-surgery. The primary outcome of the trial is 12-month change in total hip areal bone mineral density (aBMD), measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and quantitative computed tomography (QCT) derived changes in bone quality. Change in muscle mass and function will also be assessed, as well as biomarkers of bone health, turnover, and crosstalk, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Discussion: Results from the STRONG BONES trial have the potential to influence current clinical practice by determining the ability of bisphosphonate use to mitigate bone loss and concomitant fracture risk in middle-aged and older SG patients.

Weight changes during the COVID-19 shutdown in older individuals with type 2 diabetes: the Look AHEAD Study.

OBJECTIVE: The aims of this study were as follows: 1) examine weight changes in older adults (mean age = 76 years) with type 2 diabetes and overweight or obesity during the COVID-19 shutdown; and 2) compare the behavioral and psychosocial effects of the shutdown in those who had large weight losses (>5%), those who had small weight losses (2%-5%), those who remained weight stable (±2%), or those who gained weight (>2%). METHODS: Look AHEAD (Action for Health in Diabetes) participants (N = 2544) were surveyed during the COVID-19 shutdown (2020), and they self-reported their current weight, reasons for weight change, weight-related behaviors, psychosocial measures, and negative and positive effects of the pandemic on their lives. RESULTS: Comparing self-reported weight during the COVID-19 shutdown with earlier measured weight, Look AHEAD participants lost, on average, 2.2 kg during the COVID-19 shutdown: 47% lost >2%, and only 18% gained >2% (p < 0.0001). Decreases in physical activity and increases in screen time were reported frequently in all weight-change categories. Similarly, there were few differences among the categories on standardized psychosocial measures or self-reported effects of the shutdown on participants' lives. However, when differences were seen, the most negative impact was in those who gained weight. CONCLUSIONS: Although weight loss appeared more common than weight gain during the shutdown, the weight-change groups did not differ on most psychosocial and behavioral variables.

Impact of COVID-19 on life experiences reported by a diverse cohort of older adults with diabetes and obesity.

OBJECTIVE: This study aimed to measure the impact of the COVID-19 pandemic on self-reported life experiences in older adults with diabetes and obesity. METHODS: Participants were surveyed in 2020 regarding negative and positive impacts of the pandemic across domains of personal, social, and physical experiences. A cumulative negative risk index (a count of all reported negative impacts of 46 items) and a positive risk index (5 items) were characterized in relation to age, sex, race/ethnicity, BMI, and multimorbidity. RESULTS: Response rate was high (2950/3193, 92%), average age was 76 years, 63% were women, and 39% were from underrepresented populations. Women reported more negative impacts than men (6.8 vs. 5.6; p < 0.001 [of 46 items]) as did persons with a greater multimorbidity index (p < 0.001). Participants reporting African American/Black race reported fewer negative impacts than White participants. Women also reported more positive impacts than men (1.9 vs. 1.6; p < 0.001 [of 5 items]). CONCLUSIONS: Older adults with diabetes and obesity reported more positive impacts of the pandemic than negative impacts, relative to the number of positive (or negative) items presented. Some subgroups experienced greater negative impacts (e.g., for women, a greater multimorbidity index). Efforts to reestablish personal, social, and physical health after the pandemic could target certain groups.

Changes in the Prevalence of Symptoms of Depression, Loneliness, and Insomnia in U.S. Older Adults With Type 2 Diabetes During the COVID-19 Pandemic: The Look AHEAD Study.

OBJECTIVE: To evaluate changes in the prevalence of depressive symptoms, loneliness, and insomnia among older adults with type 2 diabetes from 2016 to 2020 and to assess risk factors for these conditions including demographics, multimorbidity, BMI, treatment group, and pre-coronavirus 2019 (COVID-19) measure scores. RESEARCH DESIGN AND METHODS: This was a prospective, observational study of participants from the Look AHEAD (Action for Health in Diabetes) cohort study. Data were from two assessments before COVID-19 (visit 1: April 2016-June 2018 and visit 2: February 2018-February 2020) and one assessment during COVID-19 (visit 3: July-December 2020). Surveys were administered to assess depressive symptoms, loneliness, and insomnia. RESULTS: The study included 2829 adults (63.2% female, 60.6% White, mean [SD] age 75.6 [6.0] years). The prevalence of mild or greater depressive symptoms did not change significantly between the two pre-pandemic visits (P = 0.88) but increased significantly from pre- to during COVID-19 (19.3% at V2 to 30.4% at V3; P < 0.001). Higher odds of mild or greater depressive symptoms at V3 were associated with being female (adjusted odds ratio [OR] 1.4 [95% CI 1.1-1.7]), identifying as non-Hispanic White (OR 1.4 [95% CI 1.1-1.7]), having obesity (OR 1.3 [95% CI 1.0-1.5]), and reporting mild or greater depressive symptoms at V1 (OR 4.0 [95% CI 2.9-5.4]), V2 (OR 4.4 [95% CI 3.2-5.9]), or both visits (OR 13.4 [95% CI 9.7-18.4]). The prevalence of loneliness increased from 12.3% at V1 to 22.1% at V3 (P < 0.001), while the prevalence of insomnia remained stable across visits at 31.5-33.3%. CONCLUSIONS: The prevalence of mild or greater depressive symptoms in older adults with diabetes was more than 1.6 times higher during COVID-19 than before the pandemic.