Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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. Chlorthalidone is a thiazide-like diuretic that is commonly used to reduce urinary calcium excretion in other conditions such as idiopathic hypercalciuria. Its safety and efficacy has not been specifically tested in an adolescent type 1 diabetes population. T1D subjects with hypercalciuria and who meet inclusion/exclusion criteria will be given chlorthalidone daily. Blood and urine tests, blood pressure, and glycemic control will be assessed at weekly study visits for 4 weeks.

Official Title
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Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus, Hypercalciuria

Intervention / Treatment
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* Drug: Chlorthalidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chlorthalidone<br>Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks | Drug: Chlorthalidone<br>* Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Calcium Excretion | Change in 24 hour urine calcium excretion | Assessed at baseline and at 4 weeks | 
| Hypokalemia | Serum potassium decreased to <3.5 milliequivalent/L | Assessed weekly for up to 4 weeks or until hypokalemia develops | 
| Hypercalcemia | Serum calcium increased to >10.5 mg/dL | Assessed weekly for up to 4 weeks or until hypercalcemia develops | 
| Hyperglycemia | Change in serum fructosamine | Assessed at baseline and at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, hypercalciuria