Acetazolamide and Tubuloglomerular Feedback in Persons with Type 1 Diabetes: a Clinical Trial
Trial ID: NCT05473364
Interventional - Phase 1/2 - Completed
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.
Conditions
Type 1 Diabetes
Interventions
Acetazolamide
Eligibility
Inclusion criteria
# Inclusion Criteria:
1. Males and Females ≥ 18 years at the time of consent.
2. 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.
3. Male subjects 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.
8. Able to provide written informed consent approved by an Institutional Review Board (IRB).
Exclusion criteria
# 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 aminotransferase), 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 CAD (coronary artery disease) or decompensated CHF(congestive heart failure)}.
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).
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.
13. Life expectancy \< 1 year.
14. Hospitalization within 60 days prior to screening.
15. A plan to leave the geographical area within 6 months.