Status:
COMPLETED
Vigabatrin and Insulin Sensitivity
Lead Sponsor:
Washington University School of Medicine
Conditions:
NAFLD
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is a common complication of obesity and is associated with an increased risk of developing type 2 diabetes. The hallmark feature of NAFLD is an increase in int...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04321395
Start Date
August 23 2021
End Date
May 15 2024
Last Update
January 14 2025
Active Locations (1)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110