Eligibility Module

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 @ 10:19 PM
Ignite Modification Date: 2025-12-24 @ 10:19 PM
NCT ID: NCT00994435
Eligibility Criteria: Inclusion Criteria: * Males and females * Women in fertile age should engage themselves in avoiding pregnancy during the study protocol. Before starting each experimental session a pregnancy test will be performed and pregnant women excluded from the investigation. All women will be studied in the follicular phase of their menstrual cycle 30 to 60 years old. * HbA1c between 6.5 and 8.5% (for patients with T2DM only) * BMI between 30-40 Kg /m2 Exclusion Criteria: * Past or active medical history of major endocrinological, renal, cardiac, respiratory, liver or gastro-intestinal diseases. * All Diabetic patients must have never been treated with oral hypoglycemic agents or insulin.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 30 Years
Maximum Age: 60 Years
Study: NCT00994435
Study Brief:
Protocol Section: NCT00994435