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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT00822367
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-75 years
* Type-2 diabetes mellitus for over 3 months
* A1c of 7.0 - 10.0% within the past 3 months
* Controlled with diet /exercise and/or on oral anti-diabetic agents which are non-insulin secretatgogues, i.e. Metformin and/or Pioglitazone
* Able to give informed consent
* Expected to be in the DC metropolitan for the duration of the study
* Fasting blood glucose between 70 and 250 mg/dl
Exclusion Criteria:
* Patients with type 2 diabetes mellitus treated with insulin secretagogues (sulfonylurea and non-sulfonylurea), pramlintide (Symlin), GLP-1 analogs (Byetta), insulin, or alpha-glycosidase inhibitors
* A1c under 7.0% or over 10.0%
* Fasting blood glucose \< 70 or \> 250 mg/d
* Gastrointestinal disorders affecting digestion and absorption of nutrients such as lactose intolerance, chronic diarrhea, pancreatic insufficiency.
* Clinical history of documented gastroperesis.
* Patients on hemodialysis or peritoneal dialysis
* Pregnancy
* Inability to read and/or speak English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00822367
Study Brief:
Protocol Section:
NCT00822367