NCT04321395CompletedPhase 2
Vigabatrin and Insulin Sensitivity
The Effect of Vigabatrin on Insulin Sensitivity
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
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 intrahepatic triglyceride (IHTG) content. Data from studies conducted in rodent models suggest increased IHTG content can alter hepatic vagal afferent nerve (HVAN) activity. In rodent models of obesity and NAFLD, HVAN activity is reduced leading to impaired insulin sensitivity and glucose control. The reduction in HVAN activity is likely due to increased hepatic release of GABA, an inhibitory neurotransmitter, attributable to increased expression of GABA-Transaminase (GABA-T). Pharmacological inhibition of GABA-T in obese mice by treatment with vigabatrin, an irreversible inhibitor of GABA-T improves glucose tolerance and reduces hyperinsulinemia, hyperglycemia, and insulin resistance. It is not known if vigabatrin can also improve metabolic function in people. We propose to conduct a 3-week, single-arm trial to assess the effect size of treatment with vigabatrin on the following specific aims with the larger goal of determining whether a large, randomized controlled trial investigating the effect of vigabatrin is warranted.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 23 Mar 2020
- Start date
- 23 Aug 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04321395
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 4
- From 23 Aug 2021 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous bariatric surgery
- unstable weight (\>4% change during the last 2 months before entering the study)
- major psychiatric illness (including suicidal ideation or previous suicide attempts)
- 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
Other illness
- significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease)
- cancer
- polycystic ovary syndrome
- 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)
- conditions that render subject unable to complete all testing procedures (e.g. aversion to needles, metal implants that prevent magnetic resonance imaging
- 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))
Lab values
- 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)
Other
- structured exercise ≥250 min per week (e.g., brisk walking)
- regular use of tobacco products
- excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women)
- pre-existing visual field deficits; or those at high risk of irreversible vision loss, including patients with retinopathy or glaucoma
- pregnant or lactating women
- persons who are unable or unwilling to follow the study protocol
- persons who are not able to grant voluntary informed consent
- patients with existing peripheral neuropathy
- women who have active menstrual cycles but are not using birth control (acceptable contraception includes barrier/hormonal/IUD)
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.