Effect of acetazolamide on kidney function in people with Type 1 Diabetes
Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Randomized Crossover Trial
PHASE2 · University of California, San Diego · NCT06981234
This study tests if a medication called acetazolamide can improve kidney function in people with Type 1 Diabetes.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06981234 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of acetazolamide on kidney function in individuals diagnosed with Type 1 Diabetes. It employs a randomized, double-blind, placebo-controlled, crossover design, where participants will receive either acetazolamide or a placebo in two separate treatment phases. The primary outcome will be measured using the Iohexol GFR procedure to assess changes in kidney function over the course of the study. Participants will be monitored for side effects and overall kidney health throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a stable medication regimen for Type 1 Diabetes and adequate kidney function.
Not a fit: Patients with a history of allergic reactions to acetazolamide or significant liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health and function in patients with Type 1 Diabetes.
How similar studies have performed: While the specific use of acetazolamide in Type 1 Diabetes is novel, similar studies have shown promise in using medications to protect kidney function in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- UC San Diego Altman Clinical & Translational Research Institute — La Jolla, California, United States (RECRUITING)
Study contacts
- Study coordinator: Todd May, MS
- Email: t1dresearch@health.ucsd.edu
- Phone: 858-246-2146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes