Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Randomized Crossover Trial
University of California, San Diego
Summary
The goal of this study is to learn about the effect of the study drug acetazolamide in individuals with Type 1 Diabetes. Specifically, whether acetazolamide provides benefits to the kidneys while minimizing any side effects of the drug. These changes will be measured by laboratory tests that tell us how well the kidneys are functioning.
Description
A Randomized, Double-blind, Placebo-Controlled, Crossover Trial (RCT) to explore the effects of 250mg acetazolamide in individuals with type 1 diabetes. Participants will be randomized to Treatment Group A or Treatment Group B. Randomization will be blinded, but one of these treatment groups will receive 250mg (milligram) BID (twice daily) of acetazolamide for 10 weeks - receive no study drug for 2 weeks - then receive placebo for 10 weeks; the other will receive placebo for 10 weeks - receive no study drug for 2 weeks - then receive 250mg BID of acetazolamide for 10 weeks. Both participants a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and Females ≥ 18 years at the time of consent. 2. Individuals able to become pregnant of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Individuals of child bearing potential must agree to use two methods of contraception during the entire study. 3. Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study. 4. Have a clinical diagnosis of Type 1 Diabetes on a stable medication regimen for at least 3 months. 5. eGFR (estimated glomerular…
Interventions
- DrugAcetazolamide
Acetazolamide is a potent carbonic anhydrase inhibitor that acts on the renal proximal tubule. Through this mechanism, it inhibits proximal tubule sodium reabsorption.
- DrugPlacebo
Standard pharmaceutical filler will be capsulated and packaged identically to the acetazolamide.
Location
- UC San Diego Altman Clinical & Translational Research InstituteLa Jolla, California