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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06320951
Eligibility Criteria:
Inclusion Criteria:
* Adults: Age more than or equal to 18 years of age
* Self-identified race/ethnicity as African-American or Black
* BMI ≥ 30 kg/m2
* HOMA-IR ≥ 2.5
* Blood pressure: 120-160/80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives)
* Willing to adhere to study protocol
Exclusion Criteria:
* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
* Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia)
* BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
* BMI \>45 kg/m2
* History of diabetes or fasting plasma glucose \>=126 mg/dL or HbA1C\>=6.5% or prior treatment with antidiabetics
* Estimated GFR \< 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
* Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
* Significant psychiatric illness (assessed using validated MINI questionnaire)
* Anemia (men, Hb\<13 g/dL; women, Hb \<12 g/dL)
* Inability to exercise on a treadmill
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06320951
Study Brief:
Protocol Section:
NCT06320951