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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT02942056
Eligibility Criteria:
Inclusion Criteria:
* Males and females ages 30-65 years of age
* Diagnosed Type 2 diabetes with a HbA1c of 6.5-9%, treated with either lifestyle alone or with metformin
* Weight stable for 3 months as defined by no greater than a 5% change.
Exclusion Criteria:
* Pregnancy
* Breast feeding
* Use of any other diabetes treatment other than metformin within the past 3 months
* Type 1 diabetes
* HbA1c \> 9% or less than\< 6.5%
* Liver disease with a known diagnosis of cirrhosis
* Liver Dysfunction with AST or ALT liver enzymes \> 2x upper limit of normal
* Chronic Kidney Disease with glomerular filtration rate \< 45 ml/min/1.73m2
* Anemia with hematocrit \< 30%
* TSH \> 5 or \< 0.4 mIU/L
* Coagulopathy, INR \> 1.3
* Use of warfarin or other new oral anticoagulants (dabigatran, rivaroxaban, apixaban)
* Use of subcutaneous heparin, enoxaparin, dalteparin
* Use of class 1 or class 3 anti-arrhythmic medications (disopyramide, procainamide, quinidine, mexilitine, flecanide, propafenone, amiodarone, sotalol, dronedarone, dofetilide)
* Use of immunosuppressants (methotrexate, prednisone, tacrolimus, sirolimus, azathioprine, mycophenolate, cyclosporine)
* Chronic use of benzodiazepines (midazolam, alprazolam, lorezepam, temezepam, diazepam, clonazepam, chlordiazepoxide) for the past 3 months
* Chronic use of medications that may affect body weight, glucose or lipid metabolism (e.g., anti-psychotics, anti-seizure, weight loss meds) for the past 3 months
* Patients with celiac sprue or gluten sensitive individuals
* Self-report of \> 3 alcoholic drinks per day
* Congestive heart failure (ejection fraction \< 45%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02942056
Study Brief:
Protocol Section:
NCT02942056