Status:
NOT_YET_RECRUITING
Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Hadassah Medical Organization
Conditions:
Type 2 Diabetes Mellitus in Obese
Eligibility:
All Genders
65-75 years
Phase:
NA
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)...
Detailed Description
The study will be conducted at the Center for Successful Aging with Diabetes, Sheba Medical Center and the Clinical Research Center for Diabetes, Hadassah Medical Center, Israel. The research will inc...
Eligibility Criteria
Inclusion
- Patients 65-75 years old.
- Patients who were previously diagnosed with type 2 diabetes.
- Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).
Exclusion
- 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.
- Patients who exercise regularly and in the eyes of the examiner will not benefit from the intervention program.
- Anyone who is not suitable to participate in the study, according to the researcher's discretion.
- 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).
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06497595
Start Date
August 30 2024
End Date
August 30 2025
Last Update
August 22 2024
Active Locations (2)
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1
Hadassah Medical Center
Jerusalem, Israel, 5251108
2
Sheba medical center
Ramat Gan, Israel, 52621