NCT06981234 · University of California, San Diego
Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- La Jolla, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2025 · Source of record for eligibility and locations