Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

NCT ID: NCT03325114

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2020-06-01

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.

Conditions

Type 1 Diabetes Mellitus; Hypercalciuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chlorthalidone

Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Group Type: OTHER

Chlorthalidone

Intervention Type: DRUG

Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Interventions

Chlorthalidone

Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23DK114477-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

66282

Identifier Type: -

Identifier Source: org_study_id