Status:
WITHDRAWN
Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Arizona Department of Health Services
Conditions:
Hyperinsulinism
Insulin Resistance
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
50% of Arizonans are diabetic or pre-diabetic resulting in $6.4 billion in health care and productivity costs. The severity and incidence of Type 2 Diabetes Mellitus (T2DM) is directly related to the ...
Detailed Description
Experimental Design: Hyperglycemic, hyperinsulinemic and mildly hypertensive (taking medication for hypertension or with systolic blood pressure of ≥135 mmHG) adult patients (18-60 y) with BMI ≥ 25 on...
Eligibility Criteria
Inclusion
- Participants that have BMI ≥ 25
- Participants that are mildly hypertensive(≥135 mm HG systolic BP) or taking medication for hypertension
- Hyperglycemic, hyperinsulinemic adults (18-60 y) on insulin or metformin only will be recruited based on elevated HbA1c using existing relationships between community partners and the University of Arizona Division of Endocrinology.
- Patients will be stratified into 2 treatments (Vigabatrin or Placebo) based on age, sex, and HbA1c taken at d -24.
Exclusion
- BMI \< 25
- Insulin Sensitive Individuals
- Participants with normal blood pressure (120/80 mm HG)
- Participants on any other diabetes therapy besides metformin and insulin
- If Pregnant or breast feeding
- If participants smoke
- Individuals who have complex partial seizures
- Individuals who are on other drugs to help with retinopathy or glaucoma
Key Trial Info
Start Date :
April 15 2030
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04062890
Start Date
April 15 2030
End Date
December 30 2030
Last Update
July 30 2025
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