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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01975935
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old at baseline.
* Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
* Not breastfeeding.
* Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[βhCG\]) at baseline (not applicable to hysterectomized females).
* Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period.
* Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose\>126 mg/dL or HbA1c \>6.4% or 2 hour GTT \>200 mg/dL.
* BMI ≥27 and \<45 kg/m2.
* On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of Type 2 diabetes mellitus with a stable regimen for \>12 weeks.
* Alcohol consumption of less than 40 grams/week.
* A liver US confirming presence of fatty infiltration of the liver.
* Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements.
Exclusion Criteria:
* On insulin, or other injectables for treatment of Type 2 diabetes.
* Unable to conduct home based glucose monitoring.
* HbA1c \<6.5% and \>10.0% (set to achieve uniformity in the study population).
* Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin).
* Evidence of other etiologies of viral hepatitis.
* Presence of hematologic, bone marrow and/or other abnormalities.
* Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c.
* Presence of HIV infection.
* Inability to give informed consent.
* Presence of ESRD, any type of active cancer, or \>class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination.
* Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient).
* Creatinine \>1.5 mg/dL.
* Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed.
* Unable to ambulate.
* Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina.
* Any other condition in the opinion of the investigators that may impede successful data collection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01975935
Study Brief:
Protocol Section:
NCT01975935