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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01419535
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Men and women 35 - 70 years of age
2. Subjects will be overweight or obese, with body mass index (BMI) ranging from 25 - 37 kg/m2.
3. Subjects will have either impaired fasting glucose (greater than or equal to 100 mg/dL) or a 2-hour glucose value greater than or equal to 140 mg/dl during an oral glucose tolerance test (OGTT).
OR
Mild diabetes defined as patients with a Hemoglobin A1C (HbA1C) less than or equal to 7% on no medications (diet-controlled) or on a stable dose of metformin and no other hypoglycemic agents for greater than or equal to 3 months before study entry.
4. Willing and able to comply with study requirements.
EXCLUSION CRITERIA:
1. Pregnancy and lactation
2. Diabetes requiring pharmacologic treatment. Diagnosis of diabetes will be based on the 2011 American Diabetes Association guidelines: HbA1C greater than or equal to 6.5%, fasting plasma glucose greater than or equal to 126 mg/dl, 2-hour glucose greater than or equal to 200 mg/dl during an OGTT, or a random blood glucose greater than or equal to 200 mg/dl along with classic symptoms of hyperglycemia (34)
3. Uncontrolled hypertension (blood pressure greater than or equal to 180/110 mmHg)
4. Current unstable medical conditions including clinically significant impaired cardiac function (Stage III and IV Cardiac failure), cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy as assessed on history and/or physical exam
5. Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than 3-times the upper normal limit
6. Severe renal impairment (creatinine clearance \< 30 ml/min)
7. Evidence of human immunodeficiency virus (HIV) based on history and physical examination and/or known positive HIV antibodies
8. Evidence of hepatitis C based on history and physical examination and/or known positive hepatitis C (HCV) antibody
9. History of hemorrhagic disorders or on anticoagulants
10. History of endometrial cancer, endometrial hyperplasia, unexplained vaginal bleeding, or endometrial thickness greater than 6 mm
11. Change in dose of lipid-lowering medications (including 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG Co-A) inhibitors , fibrates, niacin, ezetimibe, and over-the-counter fish oil supplements) within one month of study entry and during the study period
12. Current administration of medications known to be strong CYP3A4 inhibitors including ketoconazole, itraconazole, and erythromycin
13. Use of herbal supplements or grapefruit juice within 14 days of study drug initiation
14. Use of medications or dietary supplements that inhibit or induce CYP3A4 activity within 14 days of study drug initiation
15. Use of oral, injectable, or inhaled glucocorticoids or megestrol in the past six months
16. Use of estrogen-containing hormone therapy
17. Potential pseudocushing's states: depression or intake of \> 2 alcoholic drinks a day. Subjects will be screened for depression using the well-validated physician health questionnaire-9 (PHQ-9) with a score cut-off of greater than or equal to 10 for moderate depression (35).
18. Subjects who are actively dieting or are in a weight loss program
19. Midnight salivary cortisol \> 100 ng/dl on two separate occasions
20. Untreated thyroid dysfunction (thyroid stimulating hormone and Free thyroxine (FT4) not within normal range). If abnormal on screening labs, they will be repeated to confirm that not due to lab error or non-thyroidal illness.
21. Moderate to severe anemia (hemoglobin \< 10 g/dl)
22. Blood donation of more than 500 ml within one month prior to study enrollment
23. Subjects with a prolonged corrected Q-T interval (QTc) on electrocardiogram
24. Unable to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT01419535
Study Brief:
Protocol Section:
NCT01419535