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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT00941161
Eligibility Criteria:
Inclusion Criteria:
* 40 to 65 years old
* Ability to communicate and to meet the requirements of the study
* Signed Written Informed Consent before to conducting any study
* Body Mass Index (BMI) = 25-40kg/m2
* Stable weight in the past three months (variability \<5%)
* Meal plan and monotherapy with oral hypoglycaemic fails
* Fasting glucose = 130-270 mg/dL
* HbA1c \> 7%
* isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three days prior to making the laboratory tests
Exclusion Criteria:
* Suspected or confirmed pregnancy
* Nursing
* Inability to secure the non-pregnant during the study duration
* Hypersensitivity to any of the drugs under study
* Treatment with oral hypoglycemic or insulin
* Consumption of substance with toxic effects on any organ system
* Liver failure, heart failure, kidney failure or thyroid disease
* Chronic intake of alcohol
* Periods of acute or chronic diarrhea or vomiting
* Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride, digoxin, procainamide, quinidine, quinine, triamterene and vancomycin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00941161
Study Brief:
Protocol Section:
NCT00941161