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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02913703
Eligibility Criteria:
Inclusion Criteria:
T2DM study subjects must meet the following inclusion criteria:
* established T2DM with good to moderate glycemic control (HbA1c ≤ 8.5%)
* Diabetes treated with oral medications or lifestyle management
* BMI 25.0 - 45.0 kg/m2
Healthy control subjects must meet the following inclusion criteria:
* Fasting glucose \<100 mg/dL, as measured at screening visit
* HbA1c \< 5.7%, as measured at screening visit
* BMI 18.0 - 29.9 kg/m2
* No diagnosis of diabetes mellitus (including gestational diabetes)
* Age between 18 - 40 years
Exclusion Criteria:
All subjects will be excluded for the following reasons:
* Active infections
* History of malignant or inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease
* History of myocardial infarction or congestive heart failure
* History or active liver or renal disease (AST or ALT \>2x upper limits of normal, calculated glomerular filtration rate \[eGFR\] \<60 at screening)
* Anemia defined as hematocrit \<34% at screening visit
* Uncontrolled hypertension
* History of pituitary or adrenal disorders or neuroendocrine tumor
* History of anorexia nervosa or previous gastrointestinal surgery
* Malabsorptive GI disease, such as celiac disease
* Pregnancy or lactation
* Use of medications that alter glucose metabolism or GI function (glucocorticoids, psychotropics, niacin, narcotic, metoclopramide)
* Use of insulin or GLP-1 based therapy (i.e. DPP-4 inhibitors, GLP-1 receptor agonists)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02913703
Study Brief:
Protocol Section:
NCT02913703