Status:
TERMINATED
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Hypercalciuria
Eligibility:
All Genders
12-21 years
Phase:
PHASE2
Brief Summary
This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes
Detailed Description
Type 1 diabetes (T1D) is associated with increased urinary calcium loss, which may contribute to the low bone mineral density and increased fracture risk observed in patients with this condition. Chlo...
Eligibility Criteria
Inclusion
- Diagnosis of T1D
- Age 12-21 years
- Tanner Stage 2 or greater pubertal development
- Urine calcium excretion ≥ 4 mg/kg/day
- Able to swallow pills
Exclusion
- BMI \> 99th percentile for age (\<18 years) or BMI \>35 kg/m2 (≥ 18 years)
- Coexistent conditions that may affect calcium metabolism including:
- celiac disease
- Graves' Disease
- Addison's disease
- hypo- or hyperparathyroidism
- History of diabetes related complications including:
- neuropathy
- retinopathy
- nephropathy
- gastroparesis
- History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month
- History of any diuretic use within the past month
- Laboratory abnormalities on screening bloodwork including:
- estimated glomerular filtration rate \<90 mL/min per 1.73 m2 of body surface area
- serum calcium \>10.5 mg/dL
- serum potassium \<3.5 mmol/L
- Systolic or diastolic blood pressure \<5th percentile for age and sex50 for age \<18 years or systolic \<90 mmHg or diastolic blood pressure \<60 mmHG for age ≥18 years
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03325114
Start Date
June 28 2019
End Date
June 1 2020
Last Update
January 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester
Rochester, New York, United States, 14642