Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Randomized Crossover Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "A study nurse will insert 1 IV (intravenous) line in the hand or arm for the infusion of iohexol."
- "Serial blood draws will occur throughout the procedure relative to the time of iohexol infusion."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (1)
CA
- UC San Diego Altman Clinical & Translational Research Institute · La Jolla, CA 92037Todd May, MS · Study contact · t1dresearch@health.ucsd.eduCharles Ginsberg, MD · Principal investigatorJoe Ix, MD · Sub-investigatorJeremy Pettus, MD · Sub-investigatorMore trials in La Jolla