Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

• Status: Terminated
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Chlorthalidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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