Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT06981234
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06981234
Study Brief:
Protocol Section:
NCT06981234