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

NCT06497595 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-21

No results posted yet for this study

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

Conditions

  • Type 2 Diabetes Mellitus in Obese

Interventions

BEHAVIORAL

Wegovy (2.4 Mg Dose) + exercise & nutrition

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.

OTHER

Wegovy (2.4 Mg Dose) + usual care

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Tali Cukierman - Yaffe, professor · Division of Endocrinology, Sheba Medical Center, Israel.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-11
Primary Completion
2027-09-30
Completion
2027-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497595 on ClinicalTrials.gov