Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Overview

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

Full Title of Study: “Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2020

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.

Interventions

  • Drug: Chlorthalidone
    • Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Arms, Groups and Cohorts

  • Other: Chlorthalidone
    • Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 12 Years

    Maximum Age: 21 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Rochester
    • Collaborator
      • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • Provider of Information About this Clinical Study
      • Principal Investigator: David Weber, Assistant Professor – University of Rochester

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.