Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT06497595
Eligibility Criteria:
Inclusion Criteria:
1. Patients 65-75 years old.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
75 Years
Study:
NCT06497595
Study Brief:
Protocol Section:
NCT06497595