Recruiting
Phase 2

Acetazolamide

Sponsor:

UCLA

Code:

NCT06981234

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetazolamide

Placebo

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06981234

Start date

Aug 14, 2024

Status verified date

Jun, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group A

250mg Acetazolamide administered twice a day for 10 weeks followed by Placebo Comparator administered twice a day for 10 weeks.

experimental: Treatment Group B

Placebo Comparator administered twice a day for 10 weeks followed by 250mg Acetazolamide administered twice a day for 10 weeks.

Interventions

Acetazolamide

Acetazolamide is a potent carbonic anhydrase inhibitor that acts on the renal proximal tubule. Through this mechanism, it inhibits proximal tubule sodium reabsorption.

Placebo

Standard pharmaceutical filler will be capsulated and packaged identically to the acetazolamide.

Primary outcome measure

  • Change in mGFR percent [ Time Frame: 10 weeks ]
  • Preservation of Serum Bicarbonate [ Time Frame: 10 weeks ]
  • Preservation of Serum Potassium [ Time Frame: 10 weeks ]
  • Change is albuminuria [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Locations

UC San Diego Altman Clinical & Translational Research Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Charles Ginsberg, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-06-17.