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Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03325114
Recruitment Status : Terminated (COVID restrictions prohibit further study activies)
First Posted : October 30, 2017
Last Update Posted : June 4, 2020
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Weber, 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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Hypercalciuria Drug: Chlorthalidone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
Actual Study Start Date : June 28, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
Drug: Chlorthalidone
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Primary Outcome Measures :
  1. Urinary Calcium Excretion [ Time Frame: Assessed at baseline and at 4 weeks ]
    Change in 24 hour urine calcium excretion

  2. Hypokalemia [ Time Frame: Assessed weekly for up to 4 weeks or until hypokalemia develops ]
    Serum potassium decreased to <3.5 milliequivalent/L

  3. Hypercalcemia [ Time Frame: Assessed weekly for up to 4 weeks or until hypercalcemia develops ]
    Serum calcium increased to >10.5 mg/dL

  4. Hyperglycemia [ Time Frame: Assessed at baseline and at 4 weeks ]
    Change in serum fructosamine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03325114

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by David Weber, University of Rochester:
Study Protocol  [PDF] October 10, 2017

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Responsible Party: David Weber, Assistant Professor, University of Rochester Identifier: NCT03325114    
Other Study ID Numbers: 66282
1K23DK114477-01 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available in aggregate. No plan to share individual data at present.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Weber, University of Rochester:
type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urological Manifestations
Signs and Symptoms
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action