Type 1 DiabetesPhase 2NCT06981234
Acetazolamide in Persons With Type 1 Diabetes - Crossover Trial
A Phase 2 study testing Acetazolamide in people with Type 1 Diabetes, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, 92037
Todd May, MS, t1dresearch@health.ucsd.edu
Charles Ginsberg, MD
About this study
Official title: Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Randomized Crossover Trial
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.
Read the 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 Group A or Treatment Group B. Randomization will be blinded, but one of these treatment groups will receive 250mg (milligram) BID (twice daily) of acetazolamide for 10 weeks - receive no study drug for 2 weeks - then receive placebo for 10 weeks; the other will receive placebo for 10 weeks - receive no study drug for 2 weeks - then receive 250mg BID of acetazolamide for 10 weeks. Both participants and study staff will be blinded to the study treatment group with only the research pharmacy staff being unblinded.
To measure mGFR (measured glomerular filtration rate), an Iohexol GFR (glomerular filtration rate) procedure will be completed at the beginning and end of each treatment period. A standard protocol for the procedure will be followed that has been used in multiple studies. Iohexol (Omnipaque 300®) will be used in order to obtain a precise measure of mGRF throughout the course of the test. Iohexol will be prepared by the UCSD (University of California, San Diego) Investigational Drug Services at the ACTRI (Altman Clinical and Translation Research Institute) by drawing up 5mL into a syringe per standard pharmacy protocol. The iohexol will be dispensed to a nurse or research coordinator who will weigh the syringe prior to infusion and again after infusion to assess exact dosage delivered.
A study nurse will insert 1 IV (intravenous) line in the hand or arm for the infusion of iohexol. They will then insert a second IV in the opposite arm for blood collection. Serial blood draws will occur throughout the procedure relative to the time of iohexol infusion. A study nurse will infuse iohexol over a 1-2 minute period, flush with 10mL (milliliter) of normal saline and remove the IV. Blood samples will be collected at the following time points for mGFR analysis:
- -5 minutes (prior to iohexol infusion)
- 2 hours (120 minutes post infusion)
- 4 hours (120 minutes post infusion)
- 6 hours (120 minutes post infusion)
- Conditions
- Type 1 Diabetes
- Being tested
- Acetazolamide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Acetazolamide is a potent carbonic anhydrase inhibitor that acts on the renal proximal tubule. Through this mechanism, it inhibits proximal tubule sodium reabsorption.
PlaceboDrug
Standard pharmaceutical filler will be capsulated and packaged identically to the acetazolamide.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | 250mg Acetazolamide administered twice a day for 10 weeks followed by Placebo Comparator administered twice a day for 10 weeks. Receives: Drug: Acetazolamide; Drug: Placebo |
| Treatment Group B | Experimental | Placebo Comparator administered twice a day for 10 weeks followed by 250mg Acetazolamide administered twice a day for 10 weeks. Receives: Drug: Acetazolamide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mGFR percent
The difference in mGFR percent between acetazolamide versus placebo as measured by the iohexol procedure.
Measured: 10 weeks
Preservation of Serum Bicarbonate
The preservation of serum bicarbonate concentrations at ≥ 20 meq/L (milliequivalents per liter) from pre-dosing to post-treatment iohexol procedure.
Measured: 10 weeks
Preservation of Serum Potassium
The preservation of serum potassium concentrations at ≥ 3.2 meq/L from pre-dosing to post-treatment.
Measured: 10 weeks
Change is albuminuria
The difference in change in albuminuria between acetazolamide versus placebo as measured by urinalysis.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start14 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-blind, Placebo-Controlled, Crossover Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Breakthrough T1D
- Responsible party
- Principal investigator, Jeremy Pettus, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981234
- Sponsor's protocol ID
- 802153-2
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide and Tubuloglomerular Feedback in Persons With Type 1 Diabetes: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06981234
- Acronym / sponsor ID
- 802153-2
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Breakthrough T1D
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Group A or Treatment Group B. Randomization will be blinded, but one of these treatment groups will receive 250mg (milligram) BID (twice daily) of acetazolamide for 10 weeks - receive no study drug for 2 weeks - then receive placebo for 10 weeks; the other will receive placebo for 10 weeks - receive no study drug for 2 weeks - then receive 250mg BID of acetazolamide for 10 weeks. Both participants and study staff will be blinded to the study treatment group with only the research pharmacy staff being unblinded.
To measure mGFR (measured glomerular filtration rate), an Iohexol GFR (glomerular filtration rate) procedure will be completed at the beginning and end of each treatment period. A standard protocol for the procedure will be followed that has been used in multiple studies. Iohexol (Omnipaque 300®) will be used in order to obtain a precise measure of mGRF throughout the course of the test. Iohexol will be prepared by the UCSD (University of California, San Diego) Investigational Drug Services at the ACTRI (Altman Clinical and Translation Research Institute) by drawing up 5mL into a syringe per standard pharmacy protocol. The iohexol will be dispensed to a nurse or research coordinator who will weigh the syringe prior to infusion and again after infusion to assess exact dosage delivered.
A study nurse will insert 1 IV (intravenous) line in the hand or arm for the infusion of iohexol. They will then insert a second IV in the opposite arm for blood collection. Serial blood draws will occur throughout the procedure relative to the time of iohexol infusion. A study nurse will infuse iohexol over a 1-2 minute period, flush with 10mL (milliliter) of normal saline and remove the IV. Blood samples will be collected at the following time points for mGFR analysis:
- -5 minutes (prior to iohexol infusion)
- 2 hours (120 minutes post infusion)
- 4 hours (120 minutes post infusion)
- 6 hours (120 minutes post infusion)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-Controlled, Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: Acetazolamide, Drug: Placebo250mg Acetazolamide administered twice a day for 10 weeks followed by Placebo Comparator administered twice a day for 10 weeks. |
| Treatment Group B | Experimental | Drug: Acetazolamide, Drug: PlaceboPlacebo Comparator administered twice a day for 10 weeks followed by 250mg Acetazolamide administered twice a day for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAcetazolamide is a potent carbonic anhydrase inhibitor that acts on the renal proximal tubule. Through this mechanism, it inhibits proximal tubule sodium reabsorption. | Drug | Treatment Group A, Treatment Group B |
| PlaceboStandard pharmaceutical filler will be capsulated and packaged identically to the acetazolamide. | Drug | Treatment Group A, Treatment Group B |
Primary outcome
Change in mGFR percent
Time frame: 10 weeks
The difference in mGFR percent between acetazolamide versus placebo as measured by the iohexol procedure.
Preservation of Serum Bicarbonate
Time frame: 10 weeks
The preservation of serum bicarbonate concentrations at ≥ 20 meq/L (milliequivalents per liter) from pre-dosing to post-treatment iohexol procedure.
Preservation of Serum Potassium
Time frame: 10 weeks
The preservation of serum potassium concentrations at ≥ 3.2 meq/L from pre-dosing to post-treatment.
Change is albuminuria
Time frame: 10 weeks
The difference in change in albuminuria between acetazolamide versus placebo as measured by urinalysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide in people with Type 1 Diabetes, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd May, MS (858-246-2146, t1dresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mGFR percent (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.