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 @ 8:01 PM
Ignite Modification Date:
2025-12-24 @ 8:01 PM
NCT ID:
NCT04401904
Eligibility Criteria:
Inclusion Criteria:
1. Men or post-menopausal women.
2. Age= 60+ years.
3. All ethnic groups.
4. Body Mass index (BMI) between 30-38 kg/m2.
5. Diagnosis of pre-diabetes (HbA1c 5.7-6.4% and 2 hr. Oral Glucose Tolerance Test (OGTT) glucose between 140-199 mg/dL, evaluated at Visit 1 and 2).
6. Stable body weight (±3% for ≥3 months).
7. Willing to adhere to medication regimen for three months.
8. Montreal Cognitive Assessment score ≥21
Exclusion Criteria:
1. Diagnosis of diabetes based on American Diabetes Association (ADA) criteria
2. Impaired renal function with estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73m2 .
3. Impaired liver function with labs ≥3 times upper limits of normal range
4. Abnormal hematocrit with lower limits of ≤30%
5. Abnormal triglycerides with upper limits ≥600 mg/dL
6. Abnormal Thyroid stimulating hormone (TSH) values ≤0.3 and ≥10
7. Urinalysis results with ˃ 5-10 white blood cell count
8. Concomitant medications known to affect glucose and lipid homeostasis (anti-diabetes medications, glucocorticoids, atypical antipsychotics, anti-transplant rejection medications, anti-retrovirals).
9. Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
10. History of recent cardiovascular event in the last 6 months or Heart Failure (New York Heart Classification greater than class III-IV; recent EKG changes that suggest active heart disease
11. Poorly controlled blood pressure (systolic BP\>180, diastolic BP\>100 mmHg).
12. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and uncontrolled psychiatric disease (Subjects with depression, anxiety, PTSD, etc. can enroll if controlled and on stable medication)
13. Blood donation within 2 months prior to enrollment
14. History of frequent UTI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04401904
Study Brief:
Protocol Section:
NCT04401904