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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT06688461
Eligibility Criteria:
Inclusion Criteria:
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
* Aged ≥ 45 and ≤ 75 years
* BMI: 25-35 kg/m2
* Diagnosed as T2DM patients for at least 1 year and not longer than 5 years
* HbA1c ≥ 6.5% and ≤ 8.5%
* Fasting blood glucose \<130 mg/dL
* Women are post-menopausal (\>1 year cessation of menses),
* Being stable on medication use of metformin and/or sulfonylurea derivatives for the previous 3 months or more and other medication naïve.
Exclusion Criteria:
* Type 1 diabetes
* Patients with congestive heart failure and and/or severe renal and or liver insufficiency
* Contraindications for MRI/MRS examination
* Active diabetic foot
* Polyneuropathy or retinopathy
* Signs of active liver or kidney dysfunction
* BMI \>35 kg/m2
* Exogeneous insulin therapy
* Use of antidiabetic medication other than metformin or sulfonylurea derivatives treatment within 3 months before screening
* Use of SGLT2 inhibitors
* Unstable body weight (variations \>5kg in the last 3 months)
* Ongoing weight loss diet or use of weight loss agents
* Uncontrolled hypertension
* Engagement in regular exercise program or any other medical condition that will impede the safe performance of the experiments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06688461
Study Brief:
Protocol Section:
NCT06688461