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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.
 
ClinicalTrials.gov Identifier: NCT03325114
Recruitment Status : Terminated (COVID restrictions prohibit further study activies)
First Posted : October 30, 2017
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Weber, University of Rochester

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE October 30, 2017
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE June 28, 2019
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Official Title  ICMJE Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Hypercalciuria
Intervention  ICMJE Drug: Chlorthalidone
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Study Arms  ICMJE Chlorthalidone
Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
Intervention: Drug: Chlorthalidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
1
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2017)
20
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03325114
Other Study ID Numbers  ICMJE 66282
1K23DK114477-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be available in aggregate. No plan to share individual data at present.
Responsible Party David Weber, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP