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Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus, Hypercalciuria

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorthalidone
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, hypercalciuria

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Chlorthalidone

Arm Description

Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Outcomes

Primary Outcome Measures

Urinary Calcium Excretion
Change in 24 hour urine calcium excretion
Hypokalemia
Serum potassium decreased to <3.5 milliequivalent/L
Hypercalcemia
Serum calcium increased to >10.5 mg/dL
Hyperglycemia
Change in serum fructosamine

Secondary Outcome Measures

Full Information

First Posted
October 20, 2017
Last Updated
December 8, 2020
Sponsor
University of Rochester
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03325114
Brief Title
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Official Title
Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID restrictions prohibit further study activies
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Hypercalciuria
Keywords
type 1 diabetes, hypercalciuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorthalidone
Arm Type
Other
Arm Description
Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Chlorthalidone
Intervention Description
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Primary Outcome Measure Information:
Title
Urinary Calcium Excretion
Description
Change in 24 hour urine calcium excretion
Time Frame
Assessed at baseline and at 4 weeks
Title
Hypokalemia
Description
Serum potassium decreased to <3.5 milliequivalent/L
Time Frame
Assessed weekly for up to 4 weeks or until hypokalemia develops
Title
Hypercalcemia
Description
Serum calcium increased to >10.5 mg/dL
Time Frame
Assessed weekly for up to 4 weeks or until hypercalcemia develops
Title
Hyperglycemia
Description
Change in serum fructosamine
Time Frame
Assessed at baseline and at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available in aggregate. No plan to share individual data at present.

Learn more about this trial

Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

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