NCT03325114

Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Chlorthalidone	Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Timeline

• Start date: 2019-06-28
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-10-30
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study