Hypercalciuria, Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes, hypercalciuria
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.
Interventions
DRUGChlorthalidone
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Calcium Excretion | Assessed at baseline and at 4 weeks | Change in 24 hour urine calcium excretion |
| Hypokalemia | Assessed weekly for up to 4 weeks or until hypokalemia develops | Serum potassium decreased to \<3.5 milliequivalent/L |
| Hypercalcemia | Assessed weekly for up to 4 weeks or until hypercalcemia develops | Serum calcium increased to \>10.5 mg/dL |
| Hyperglycemia | Assessed at baseline and at 4 weeks | Change in serum fructosamine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorthalidone Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Hypercalcemia
Serum calcium increased to \>10.5 mg/dL
Time frame: Assessed weekly for up to 4 weeks or until hypercalcemia develops
Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
Primary
Hyperglycemia
Change in serum fructosamine
Time frame: Assessed at baseline and at 4 weeks
Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
Primary
Hypokalemia
Serum potassium decreased to \<3.5 milliequivalent/L
Time frame: Assessed weekly for up to 4 weeks or until hypokalemia develops
Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
Primary
Urinary Calcium Excretion
Change in 24 hour urine calcium excretion
Time frame: Assessed at baseline and at 4 weeks
Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.