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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00843232
Eligibility Criteria:
Inclusion Criteria:
* Stable weight (\<5% variation) within the last three months
* Age: 35 to 50 years old for middle-age group, and 65 to 80 y old for elderly group
* Body mass index (BMI): 20 to 29.9kg/m2
* T2DM with diagnosis above 35 years and less than 5 years (Middle-age group)
* T2DM with diagnosis above 65 years and less than 5 years (Elderly group)
* Use of oral antidiabetic drugs (that must at stable dose within the last 3 months)
* Not have participated in any study of intervention with drugs in the last six months.
Exclusion Criteria:
* Use of estrogen, progestogen, active antipsychotics and systemic corticosteroids
* Use of DPP-IV inhibitors and incretin mimetics (current or within 1 month before)
* Continuous use of insulin or glitazone
* Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
* Smoking
* Obesity
* Uncontrolled systemic or disabling diseases
* T2DM treated by non pharmacological methods
* Patients submitted to bariatric surgery
* Latent autoimmune diabetes of the adult (positive anti-GAD antibodies)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT00843232
Study Brief:
Protocol Section:
NCT00843232