Lifestyle program plus weekly semaglutide for older adults with type 2 diabetes and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll older adults with type 2 diabetes and overweight or obesity who are receiving Wegovy (semaglutide). Participants are randomized to either a multi-disciplinary intervention consisting of online exercise sessions and individualized nutrition counseling plus semaglutide, or to semaglutide with standard health recommendations. Semaglutide is dosed weekly and titrated up to 2.4 mg, with a 6-month treatment period. The primary goals are to see if the intervention slows loss of muscle mass, preserves muscle strength, and maintains physical function compared with control. The study is conducted at centers in Israel with a team including endocrinology, nutrition, physical therapy, exercise science, imaging, and biostatistics experts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with significant hearing or visual disability.
2. Patients with Estimated Glomerular Filtration Rate (eGFR)\<30 ml/min/1.73 m2.
3. Patients who are in active nutritional therapy.
4. 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.
5. Patients who reported a weight loss of \>5kg within 90 days of screening
6. Patients who were on Glucagon-like peptide-1 receptor agonists (GLP-1-RA) treatment during the last 3 months.
7. Patients with musculoskeletal disorders, which, by the judgment of the investigators, would limit their ability to perform the exercise training.
8. Patients with neurological diseases, which by the judgment of the investigators, would affect their ability to participate in the trial.
9. Patients with a history of amputation that impairs their ability to participate in the exercise program.
10. Patients with disabilities, which, by the judgment of the investigators, would affect their ability to participate in the trial.
11. Patients who use a walking aid.
12. Patients who are currently using systemic steroids.
13. Patients with active oncological diseases, excluding non-melanoma skin cancer.
14. 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.
15. Patients who were hospitalized in the past month.
16. Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.
17. Anyone who is not suitable to participate in the study, according to the researcher's discretion.
18. 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).
19. 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.

Where it's running

• Sheba medical center
  Ramat Gan, Israel, Israel Recruiting
• Hadassah Medical Center
  Jerusalem, Israel, Israel Not yet recruiting

Study contacts

• Principal investigator: Tali Cukierman - Yaffe, professor — Division of Endocrinology, Sheba Medical Center, Israel.
• Study coordinator: Tali Cukierman - Yaffe, professor
• Email: tcukierm@gmail.com
• Phone: 0523824704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.