Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Stopped early · Phase 2

Conditions studied: Type 1 Diabetes Mellitus, Hypercalciuria

In brief

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

Key facts

Study ID

NCT03325114

Run by

University of Rochester

People needed

1

Starts

2019-06-28

Expected to finish

2020-06-01

Last updated by the study team

2021-01-05

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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