Exercise and Nutrition Program for Diabetics with Obesity
Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
Recruiting
N/AInterventional Study
Type 2 Diabetes Mellitus in Obese
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Sheba Medical Center · Government
Who this trial is looking for
This trial is looking for older adults with type 2 diabetes and obesity who want to slow down muscle loss. Participants will take a medication called Semaglutide and join an online exercise and nutrition program for 6 months.
Are You a Good Fit for This Trial?
Must be takingSemaglutide
You may be able to join if
I am 65 years old or older.
I have been diagnosed with type 2 diabetes.
I am overweight or obese.
You may not be able to join if
I have significant hearing or visual disabilities.
I have severe kidney issues.
I am on active nutritional therapy.
I recently changed my diet or lost more than 5% of my weight.
I reported losing more than 5kg in the last 90 days.
I have musculoskeletal disorders affecting my ability to exercise.
I have neurological diseases affecting my participation.
I am currently hospitalized.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-discip…
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.
Trial Locations
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Eligibility Criteria
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 Filtr…
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.
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