Status:
RECRUITING
Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Breakthrough T1D
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mini...
Detailed 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 Gr...
Eligibility Criteria
Inclusion
- Males and Females ≥ 18 years at the time of consent.
- 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.
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study.
- Have a clinical diagnosis of Type 1 Diabetes on a stable medication regimen for at least 3 months.
- eGFR (estimated glomerular filtration rate) ≥ 45ml/min/1.73m2
- Serum bicarbonate ≥ 24 meq/L
- Negative urine toxicology screen.
- Able to provide written informed consent approved by an Institutional Review Board (IRB).
Exclusion
- History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets.
- 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).
- Serum hemoglobin A1c \> 10.0%
- Serum hemoglobin concentration of \<8 g/dL.
- Use of \> 4 anti-hypertensives, or systolic blood pressure \>160mm Hg at the screening visit.
- Use of loop, thiazide or potassium sparing diuretics.
- 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)).
- Institutionalized individual (prisoners, patients with signification mental illness, or nursing home residents).
- Active pregnancy, breastfeeding, or planning to become pregnant during the study period.
- Current participation in another clinical trial (observational studies are exempted) trial.
- In the opinion of the investigators, inability to adhere to the study medical regimen or comply with recommendations.
- Inability or unwillingness to travel to study visits.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06981234
Start Date
August 14 2024
End Date
June 1 2027
Last Update
June 17 2025
Active Locations (1)
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1
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037