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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT02783703
Eligibility Criteria:
Inclusion Criteria:
* English-speaking
* Males and female ambulatory subjects
* Self-identify as Caucasian/White or Black/African American
* Body Mass Index \<=45
Exclusion Criteria:
* Diagnosis of type 2 diabetes or hemoglobin A1c \>6.5
* Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
* Daily use of oral steroids
* Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of \>3%)
* Use of any weight loss medications or sex hormone therapy
* Daily use of psychotropic medications (for schizophrenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, psychotic disorder, mania)
* Chronic kidney disease, on dialysis or history of renal transplant
* Poorly controlled cardiovascular disease or congestive heart failure
* Severe peripheral vascular disease or severe liver disease
* Cancer
* A condition requiring use of oxygen such as severe chronic obstructive pulmonary disease
* Women who are pregnant, lactating, or actively trying to become pregnant
* Any cognitive or other disorders that may interfere with participation or ability to follow restrictions
* Abnormal TSH levels (\<0.01 or \>1.5x the upper limit)
* Weight \>450 lb (205 kg) or height \> 6'6"
* Severe claustrophobia
* Has had or is preparing for bariatric surgery (pre- or post-bariatric)
* Medically required use of anticoagulant therapies
* Current use of MCT oil
* Anemia (hemoglobin and/or hematocrit outside sex-specific normal ranges)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02783703
Study Brief:
Protocol Section:
NCT02783703