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

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 65-75) 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 exercise and 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 participate in a 26-week, tri-weekly, exercise program. One 45-minute exercise session will be provided via a virtual meeting platform each week and recorded. The participants will be asked to independently repeat each recorded session twice on separate, non-consecutive days of the week without supervision. The program will focus on progressive resistance exercises using body weight, a resistance band and various household items. A weekly follow-up call will be conducted to gather feedback and monitor adherence along with a personal exercise diary that each participant will fill out and bring to each on-site visit. Each exercise session will be performed in small groups and will be administered by a fitness specialist. In addition, participants will receive personal individualized nutritional counseling which will be administered every 2-4 weeks online via ZOOM. A certified dietitian will conduct all diet sessions.

OTHER

Wegovy (2.4 Mg Dose) + usual care

Participants will receive dietary guidance as customary among patients with type 2 diabetes (T2D) and obesity monitored in a diabetes clinic. Additionally, general recommendations for physical activity (PA) according to the medical guidelines for PA for T2D will be given. Guidelines recommend 150 minutes or more of moderate to vigorous-intensity aerobic activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity, or engage in 75 minutes/week of vigorous-intensity or interval training (for more physically fit individuals). Incorporate 2-3 sessions/week of resistance exercise on nonconsecutive days, decrease sedentary behavior and add flexibility and balance training 2-3 times/week. Participants in the GHRG will be requested to fill out an exercise diary (report on unsupervised training days) and a 2-day food diary for periodic monitoring which they will bring with them to each on-site visit.

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

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-30

Primary Completion

2025-01-30

Completion

2025-08-30

Countries

• Israel

Study Locations