Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

University of Rochester

Status and phase: Terminated; Phase 2

Conditions: Type 1 Diabetes Mellitus; Hypercalciuria

Treatments: Drug: Chlorthalidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03325114

66282

1K23DK114477-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 12 to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Chlorthalidone

Other group

Description:

Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Treatment:

Drug: Chlorthalidone