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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT02839512
Eligibility Criteria:
Inclusion Criteria:
* 18 to 65 years of age
* A BMI ≥ 30 kg/m2 and \< 50 kg/m2 If subject has Type 2 Diabetes
* HbA1c ≥ 6.5% and ≤ 9%
* Fasting plasma glucose greater than 110 mg/dl
* Treatment with up to 2 oral diabetic medications
* Able to understand and sign informed consent document
* If subject is female, she must commit to not becoming pregnant for 18 months and agree to use of contraceptives during this period
Exclusion Criteria:
* Any conditions for which endoscopy/colonoscopy would be contraindicated.
* Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
* Previous abdomino-pelvic surgery that may result in adhesions or anatomical changes that may interfere with placement of the GIW device.
* Diagnosis of Type 2 diabetes less than 6 months
* More than 2 oral diabetic medications
* Use of insulin
* If on metformin, history of polycystic ovarian syndrome (PCOS)
* Use of Dipeptidyl peptidase-4 (DPP-4) inhibitors
* Use of GLP-1 agonists
* Use of Use of alpha-glucosidase inhibitors
* Type 1 Diabetes
* Unable or unwilling to perform home blood glucose monitoring
* History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
* History of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
* Any blood coagulation disorder
* Implanted cardiac pacemaker, defibrillator or other implanted electric device - Ongoing systemic infection
* Chronic pancreatitis
* Chronic liver disease of any cause
* Poorly controlled psychiatric disease (e.g. ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis)
* Any history of an eating disorder within the past 5 years
* Pre-existing severe comorbid cardio-respiratory disease (e.g. congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism)
* Uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02839512
Study Brief:
Protocol Section:
NCT02839512