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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-08-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 diagnosis of cirrhosis by imaging of physician; \> 14 drinks/week; AST (Aspartate Transferase), ALT (Alanine Aminotransferase), or total bilirubin \> 2 times the upper limit of normal). 3. Serum hemoglobin A1c \> 10.0% 4. Serum hemoglobin concentration of \<8 g/dL. 5. Use of \> 4 anti-hypertensives, or systolic blood pressure \>160mm Hg at the screening visit. 6. Use of loop, thiazide or potassium sparing diuretics. 7. A medical condition requiring active surgical or medical intervention whose urgency would preclude participation in this study at the discretion of the site investigator (active cardiac or pulmonary conditions, ongoing ischemia or cardiac symptoms, uncorrected Coronary Artery Disease (CAD) or decompensated congestive heart failure (CHF)). 8. Institutionalized individual (prisoners, patients with signification mental illness, or nursing home residents). 9. Active pregnancy, breastfeeding, or planning to become pregnant during the study period. 10. Current participation in another clinical trial (observational studies are exempted) trial. 11. In the opinion of the investigators, inability to adhere to the study medical regimen or comply with recommendations. 12. Inability or unwillingness to travel to study visits.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06981234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06981234 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06981234 currently recruiting?
Yes, NCT06981234 is actively recruiting participants. Contact the research team at t1dresearch@health.ucsd.edu for enrollment information.
Where is the NCT06981234 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT06981234 clinical trial?
NCT06981234 is sponsored by University of California, San Diego. The trial plans to enroll 25 participants.
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