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

NCT06497595 | Not Yet 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 65-75) 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. 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 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.

multi-disciplinary intervention group (MDIG)

Wegovy (2.4 Mg Dose) + usual care OTHER

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.

general health recommendations control group (GHRG)

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients 65-75 years old.
• 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, 5251108, Israel

Location

Sheba medical center

Ramat Gan, 52621, Israel

Location

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: August 30, 2024
• Primary Completion: January 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

IL (2)