Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03325114
• Other study ID #: 66282
• Secondary ID: 1K23DK114477-01
• Status: Terminated
• Phase: Phase 2
• Start date: June 28, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypercalciuria
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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