Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Phase 2

Terminated

• Conditions: Type 1 Diabetes Mellitus; Hypercalciuria
• Interventions: Drug: Chlorthalidone

• Registration Number: NCT03325114
• Lead Sponsor: University of Rochester

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. 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.

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Study Start: 2019-06-28
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2020-12
• Results First Submitted: 2020-12-08
• Results First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Results First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorthalidone	Chlorthalidone	Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States