Exercise and Nutritional Intervention to Reduce the Risk of Sarcopenia in Older Adults With Type 2 Diabetes and Obesity Treated With Semaglutide: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Thigh muscle volume (TMV)
研究概览
简要总结
This study aims to test whether a multi-disciplinary intervention involving exercise and nutrition can slow down the decline in physical function, muscle strength and mass in older adults (aged 65 and above) with Type 2 diabetes (T2D) and obesity treated with Semaglutide.
The main questions it aims to answer are:
In older people with T2D and obesity, treated with Semaglutide, does a multi-disciplinary intervention of exercise and nutrition compared to standard health recommendations:
- Reduce the rate of decline in muscle mass?
- Reduce the rate of decline in muscle strength?
- Reduce the rate of decline in physical function?
Participants will:
Administer Semaglutide once weekly for 6 months. Visit the clinic once every 8 weeks for checkups and tests. Keep a diary of their food consumption. Participants in the intervention group will participate in an online exercise program and will receive personal nutritional counseling.
详细描述
The study will be conducted at the Center for Successful Aging with Diabetes, Sheba Medical Center and the Clinical Research Center for Diabetes, Hadassah Medical Center, Israel. The research will include a team with expertise in endocrinology, nutritional interventions, physical therapy, fitness training, medical imaging and biostatistics.
Participants aged 65 years and older, with both type 2 diabetes (T2D) and overweight / obesity, will be randomly allocated to either a (1) Semaglutide and multi-disciplinary intervention group (MDIG) comprised of exercise and diet or (2) Semaglutide and general health recommendations control group (CG). The drug dosage (Wegovy, Semaglutide) will be gradually increased every 4 weeks starting with 0.25 milligrams (mg) on week 0 and reaching 2.4 mg by week 16 as per the Wegovy label and maintained at 2.4 mg until the end of the trial (week 26). If a participant is unable to tolerate the 2.4 mg subcutaneous weekly dose (SC QW) of Semaglutide, the highest tolerable dose will be administered, with continued efforts to gradually increase the dose over time.
Participants in the MDIG will undergo a once-weekly group exercise training that will be delivered online, followed by 2 unsupervised home-based sessions. Weekly phone calls will be used in order to measure adherence to the exercise program. In addition, personal nutritional counseling will be administered by a certified dietitian every 2 weeks for the first 4 weeks and every 4 weeks for the remaining 22 weeks via a virtual meeting platform (i.e., "ZOOM"). In addition, a 3-day food diary will be filled out for tracking and documentation. All group exercise training will be conducted via a virtual meeting platform as well. Participants allocated to the CG will receive general health recommendations both verbally and in writing and continue with their regular daily routine. They will also be required to complete a personal food diary.
Visit 1- screening: All potential eligible subjects will be invited for a screening Visit, during which the following information would be obtained: a) Informed consent; b) Eligibility criteria form; c) Physician interview and examination; d) Demographic and medical information; e) Medical History and recent blood work.
After being allocated to the two study arms, 4 additional measurement visits will be booked (Fig.1, appendix A): (1) baseline - week 0 (visit 2), (2) week 8 (visit 3), (3) week 16 (visit 4), and (4) end of treatment - week 26 (visit 5). The following information will be collected on each visit: a) Anthropometric measurements, including waist and hip circumference, waist to hip ratio, weight, height and body mass index (BMI, calculated in kg/m2); b) Body composition measured with MRI, DXA and BIA; c) Functional and strength assessments, including balance, aerobic capacity, gait speed and strength tests; d) Blood pressure (BP) and heart rate (HR) tests; e) Blood and urine samples, including hemoglobin A1C test (HbA1C) (only on visits 2, 4 and 5); f) RMR test (only on visits 2, 4 and 5); g) Quality of life and sarcopenia questionnaires and frailty assessment (only on visits 2 and 5); h) Semaglutide distribution, usage, and titration guidance will be provided at visits 2 and 3, and every 4 weeks throughout the study; i) Collection and recording of partly used and full pens for estimation of Semaglutide adherence (only on visits 3-5); j) Adverse events collection (only on visits 3-5); k) Cognitive tests (only on visits 2 and 5); l) Installation of an application on the mobile phone for continuous movement monitoring (only on visit 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years and above.
- •Patients who were previously diagnosed with type 2 diabetes.
- •Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).
排除标准
- •Patients with significant hearing or visual disability.
- •Patients with Estimated Glomerular Filtration Rate (eGFR)<30 ml/min/1.73 m
- •Patients who are in active nutritional therapy.
- •Patients who changed their diet recently (< 1 month) and/or in a weight-loss program with >5% weight loss or used anti-obesity drugs in the last 3 months.
- •Patients who reported a weight loss of >5kg within 90 days of screening
- •Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment during the last 3 months.
- •Patients with musculoskeletal disorders, which, by the judgment of the investigators, would limit their ability to perform the exercise training.
- •Patients with neurological diseases, which by the judgment of the investigators, would affect their ability to participate in the trial.
- •Patients with a history of amputation that impairs their ability to participate in the exercise program.
- •Patients with disabilities, which, by the judgment of the investigators, would affect their ability to participate in the trial.
- •Patients who use a walking aid.
- •Patients who are currently using systemic steroids.
- •Patients with active oncological diseases, excluding non-melanoma skin cancer.
- •Patients with diagnosed dementia or cognitive impairment that, in the view of the researchers, may impair their ability to sign a consent form or participate in the trial.
- •Patients who were hospitalized in the past month.
- •Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.
- •Anyone who is not suitable to participate in the study, according to the researcher's discretion.
- •Any contraindication to Magnetic resonance imaging (MRI) (e.g., MRI non-compatible cardiac implantable electronic device, metallic foreign bodies, implantable neurostimulation system, cochlear implants/ear implant, non-removable drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips which), or inability to perform an MRI scanner (e.g., claustrophobia).
- •Patients who do not fit within the measurement field of view of the Dual-energy X-ray absorptiometry (DXA) scanner in a supine position with the arms next to the body.
研究组 & 干预措施
multi-disciplinary intervention group (MDIG)
Participants in this group will receive Semaglutide 2.4 mg SC QW and take part in a multi-disciplinary intervention comprised of home-based exercise and nutritional counselling for the 26-week trial duration.
干预措施: Wegovy (2.4 Mg Dose) + exercise & nutrition (Behavioral)
general health recommendations control group (GHRG)
Participants in this group will receive Semaglutide 2.4 mg SC QW and general health recommendations for the 26-week trial duration.
干预措施: Wegovy (2.4 Mg Dose) + usual care (Other)
结局指标
主要结局
Thigh muscle volume (TMV)
时间窗: 26 weeks
Change in TMV from baseline to week 26
次要结局
- Timed up and go (TUG) test score(26 weeks)
- 6-minute walk test (6MWT) score(26 weeks)
- Short physical performance battery (SPPB) test score(26 weeks)
- Muscle quality (muscle fat infiltration)(26 weeks)
- Thigh muscle volume (TMV)(26 weeks)
- Sit to stand test (STS) score(26 weeks)
- 10-meter walk test (10MWT) score(26 weeks)
- Fried Frailty scale(26 weeks)
- Fat distribution(26 weeks)
- Total lean mass(26 weeks)
- Appendicular lean mass(26 weeks)
- Hand grip strength test score(26 weeks)
研究者
Dr. Tali Cukierman-Yaffe
professor
Sheba Medical Center