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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03207893
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Between the ages of 21 and 80
* Failed on an oral medication regimen (HbA1c \> 7.5%).
Exclusion Criteria:
* Takes insulin
* Took medications in the last 3 months that impede weight loss (e.g., prednisone)
* Pregnant or contemplating pregnancy in the next 12 months
* Conditions that preclude increasing physical activity (e.g. severe neuropathy, cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke)
* Severe mental disease (e.g. manic depressive illness, severe depression, or active substance abuse)
* Undergoing treatment for cancer
* History of lactic acidosis
* Marked renal impairment (eGFR \< 45; stage 3b chronic kidney disease)
* Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
* Cannot read English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03207893
Study Brief:
Protocol Section:
NCT03207893