Clinical trial NCT03325114: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Hypercalciuria
Keywords: type 1 diabetes
hypercalciuria
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-10-30
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary Calcium Excretion
timeFrame: Assessed at baseline and at 4 weeks
measure: Hypokalemia
timeFrame: Assessed weekly for up to 4 weeks or until hypokalemia develops
measure: Hypercalcemia
timeFrame: Assessed weekly for up to 4 weeks or until hypercalcemia develops
measure: Hyperglycemia
timeFrame: Assessed at baseline and at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: