NCT06981234 Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
| NCT ID | NCT06981234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 filtration rate) ≥ 45ml/min/1.73m2 6. Serum bicarbonate ≥ 24 meq/L 7. Negative urine toxicology screen. 8. Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: 1. History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets. 2. Liver disease (clinical dia
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