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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT04321395
Eligibility Criteria:
Inclusion Criteria:
* age 25-60 years old
* BMI 30.0-49.9 kg/m2
* IHTG content ≥5.6
* Homeostatic Model of Insulin Resistance (HOMA-IR) Score\>2.5.
Exclusion Criteria:
* previous bariatric surgery
* structured exercise ≥250 min per week (e.g., brisk walking)
* unstable weight (\>4% change during the last 2 months before entering the study)
* significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease)
* cancer
* polycystic ovary syndrome
* major psychiatric illness (including suicidal ideation or previous suicide attempts)
* conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
* regular use of tobacco products
* excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women)
* use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
* pre-existing visual field deficits; or those at high risk of irreversible vision loss, including patients with retinopathy or glaucoma
* pregnant or lactating women
* conditions that render subject unable to complete all testing procedures (e.g. aversion to needles, metal implants that prevent magnetic resonance imaging
* persons who are unable or unwilling to follow the study protocol
* persons who are not able to grant voluntary informed consent
* patients at risk for severe anemia (hemoglobin \< 14 g/dL (men) or \<12.0 g/dL (women) and/or hematocrit \<40% in men or \< 37% in women)
* patients with history of lower limb edema (risk of heart failure)
* patients with mild or more severe renal insufficiency (CrCl \<100 mL/min (men) or \<80 mL/min (women))
* patients with existing peripheral neuropathy
* women who have active menstrual cycles but are not using birth control (acceptable contraception includes barrier/hormonal/IUD)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04321395
Study Brief:
Protocol Section:
NCT04321395