Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide

NCT06497595 | Recruiting

• 1 other identifier: 1072-24-SMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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:

1. 1.Reduce the rate of decline in muscle mass?
2. 2.Reduce the rate of decline in muscle strength?
3. 3.Reduce the rate of decline in physical function?

Conditions

Type 2 Diabetes Mellitus in Obese

Keywords

older adults; sarcopenia; obesity; type 2 diabetes; semaglutide; exercise; physical capacity

Outcome Measures

Primary Outcomes (1)

• Thigh muscle volume (TMV)

  Change in TMV from baseline to week 26

  26 weeks

Secondary Outcomes (12)

• Thigh muscle volume (TMV)

  26 weeks

• Sit to stand test (STS) score

  26 weeks

• Hand grip strength test score

  26 weeks

• Timed up and go (TUG) test score

  26 weeks

• 6-minute walk test (6MWT) score

  26 weeks

Study Arms (2)

multi-disciplinary intervention group (MDIG)

EXPERIMENTAL

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.

Behavioral: Wegovy (2.4 Mg Dose) + exercise & nutrition

general health recommendations control group (GHRG)

ACTIVE COMPARATOR

Participants in this group will receive Semaglutide 2.4 mg SC QW and general health recommendations for the 26-week trial duration.

Other: Wegovy (2.4 Mg Dose) + usual care

Interventions

Wegovy (2.4 Mg Dose) + exercise & nutrition BEHAVIORAL

Participants will follow a 26-week, tri-weekly exercise program. One supervised 45-minute session will be conducted weekly via Zoom and recorded, with participants requested to repeat it twice independently on non-consecutive days. The program will include progressive resistance exercises alongside aerobic, balance, and flexibility training. Exercise intensity will be monitored using the Borg RPE scale, progressing gradually to a "somewhat hard" effort level (RPE 13-14). Weekly follow-up calls will track adherence and progress. The nutritional program will include individualized counseling, focusing on protein intake for sarcopenia prevention and personalized dietary adjustments based on health conditions and activity levels. Dietary intake will be monitored through food diaries and an adapted Food Frequency Questionnaire (FFQ). Weight will be tracked through self-reported measurements and on-site visits throughout the study.

multi-disciplinary intervention group (MDIG)

Wegovy (2.4 Mg Dose) + usual care OTHER

Participants allocated to the CG will receive general recommendations for PA according to the medical guidelines for PA for T2D. Guidelines recommend 150 minutes of moderate to vigorous-intensity aerobic activity per week, with no more than 2 consecutive days without activity, or engage in 75 minutes/week of vigorous-intensity or interval training. Incorporate 2-3 sessions/week of resistance exercise, decrease sedentary behavior and add flexibility and balance training 2-3 times/week. PA habits will be collected through a questionnaire during the first and final visit. Nutritional guidance will focus on adequate protein intake and reduced carbohydrate consumption, emphasizing fiber-rich, minimally processed sources. Dietary intake will be evaluated through an FFQ and 3-day food diaries at baseline and study completion.

general health recommendations control group (GHRG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients 65 years and above.
• Patients who were previously diagnosed with type 2 diabetes.
• Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).

You may not qualify if:

• Patients with significant hearing or visual disability.
• Patients with Estimated Glomerular Filtration Rate (eGFR)\<30 ml/min/1.73 m2.
• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Hadassah Medical Organization: collaborator

Study Sites (2)

Hadassah Medical Center

Jerusalem, Israel, 5251108, Israel

NOT YET RECRUITING

Sheba medical center

Ramat Gan, Israel, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Obesity; Diabetes Mellitus, Type 2; Motor Activity

Interventions

semaglutide; Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Tali Cukierman - Yaffe, professor

  Division of Endocrinology, Sheba Medical Center, Israel.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tali Cukierman - Yaffe, professor

CONTACT

0523824704; tcukierm@gmail.com

Tal Yahalom-Peri

CONTACT

0544647640; Tal.yahalom@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 12, 2024
• Study Start: May 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

IL (2)