NCT05473364CompletedPhase 1/2
Acetazolamide in Persons With Type 1 Diabetes - Dose Finding
Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Dose Finding Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
This is a dose finding trial where participants will receive escalating doses of acetazolamide, each for a 2-week dosing period followed by a 2-week washout period. The three doses examined will be open-label 62.5mg twice daily, 125mg twice daily, and 250mg twice daily of acetazolamide. A baseline Iohexol GFR (glomerular filtration rate) measurement will be performed prior to the first administration of each acetazolamide dose and then again following each dosing period. Including a screening visit and a follow-up visit, there will be a total of 8 study visits over approximately 16 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 22 Jul 2022
- Start date
- 20 Mar 2023
- Primary completion date
- 23 Feb 2024
- Lead sponsor
- University of California, San Diego
- Diseases
- Type 1 diabetes
- NCT number
- NCT05473364
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 12
- From 20 Mar 2023 to the primary completion date, 23 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalization within 60 days prior to screening.
Other illness
- History of allergic reaction to acetazolamide, another carbonic anhydrase inhibitor, or any of the inactive ingredients in the acetazolamide tablets.
- 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 CAD (coronary artery disease) or decompensated CHF(congestive heart failure)}.
- Institutionalized individual (prisoners, patients with signification mental illness, or nursing home residents).
Lab values
- Liver disease (clinical diagnosis of cirrhosis by imaging of physician; \> 14 drinks/week; AST (aspartate aminotransferase), 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 loop, thiazide or potassium sparing diuretics.
Other
- Use of \> 4 anti-hypertensives, or systolic blood pressure \>160mm Hg at the screening visit.
- Active pregnancy, breastfeeding, or planning to become pregnant during the study period.
- Current participation in another clinical trial (observational studies are exempted).
- 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.
- Life expectancy \< 1 year.
- A plan to leave the geographical area within 6 months.
Who the study is looking for
- Males and Females ≥ 18 years at the time of consent.
- Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study.
- Male subjects 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC San Diego Altman Clinical & Translational Research Institute Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.