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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02757560
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) from 25-35 kg/m2
* normal glucose tolerance (NGT) diagnosis based on fasting glucose value 100mg/dl and 2 hr glucose \<140 mg/dl after a standard 75 gm glucose load; impaired fasting glucose (IFG) on fasting glucose value ≥100 and \<126 mg/dl and 2 hr glucose \<140 mg/dl; impaired glucose tolerance (IGT) based on 2 hr glucose ≥140 and \<200 mg/dl and a fasting glucose \<126 mg/dl
* Fasting triglyceride levels \<500 mg/dl
Exclusion Criteria:
* Type 1 or 2 diabetes mellitus or a hemoglobin A1c value ≥ 6.5 mg/dl
* Any diabetes medications in the past month, thiazolidinedione medications in the prior 3 months or prior regular use of insulin
* Use of diets, medications (e.g., steroids, weight loss medications ) or current or planned behavior changes (e.g. acute weight loss, exercise training) that will influence changes in IR
* Creatinine \>2.0 mg/dl or other laboratory evidence of significant active disease, including hepatic enzyme elevation \>2x normal and anemia, known "Nonalcoholic Fatty Liver Disease", bleeding risk
* Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems, or recent history of nausea or vomiting
* Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
* Cardiovascular event, stable or unstable angina or other major illness in the past 6 months
* Current regular use of anti-inflammatory medications (e.g. salicylates \> 1 gm/ day) or antioxidants in excess of a daily multi-vitamin, including supplements (e.g. fish oils)
* Lipid lowering medications must be at a stable dose for at least 2 months prior to participation
* Ethanol consumption more than 4 oz day; more than occasional smoker
* Reproductively active women not on contraceptives
* Known allergies, prior reactions or contraindications to proposed clinical agents (e.g Octreotide)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02757560
Study Brief:
Protocol Section:
NCT02757560