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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT01607450
Eligibility Criteria:
Inclusion Criteria:
* Age 18-60
* Lean subjects will be defined as having a BMI \<25 kg/m2, in good general health, taking no regular medications
* Diabetic subjects will be obese (BMI \>30 kg/m2 but \<40 kg/m2), HbA1c 7.0-10.0%, treated with diet and exercise plus oral agents or injected insulin. All diabetic subjects will be treated with injected insulin for 2 weeks prior to study, to avoid potential confounding effects of other antidiabetic agents.
Exclusion Criteria:
* Chronic illnesses or infections (other than type 2 diabetes)
* Known coronary artery disease or abnormal ECG on screening evaluation
* Blood pressure \> 160/100 mmHg on two occasions during screening evaluations. Current use of 3 or fewer blood pressure medications with blood pressure below this cutpoint will be acceptable.
* Total cholesterol \> 240 mg/dL. Current use of 2 or fewer lipid lowering agents with cholesterol below this cutpoint will be acceptable.
* Diabetic subjects: Treatment with a GLP-1 agonist or DPP4 inhibitor within the past 6 months
* Known intolerance to injected GLP-1 agonist
* Treatment with PPAR gamma agonists currently or within the past 6 months
* Recognized microvascular complications (retinopathy, nephropathy, neuropathy)
* Unwillingness or inability to use injected insulin for the purposes of this study
* Chronic pain or other physical conditions which limit ability to remain supine for the duration of the study protocol
* History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within PET scanner gantry for the duration of the imaging protocol
* Occupational, investigational or other known radiation exposure which, together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a contiguous 12 month period
* For female participants, current pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01607450
Study Brief:
Protocol Section:
NCT01607450