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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK114477-01 | U.S. NIH Grant/Contract | View source |
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COVID restrictions prohibit further study activies
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorthalidone | Other | Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorthalidone | Drug | Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Calcium Excretion | Change in 24 hour urine calcium excretion | Assessed at baseline and at 4 weeks |
| Hypokalemia | Serum potassium decreased to <3.5 milliequivalent/L | Assessed weekly for up to 4 weeks or until hypokalemia develops |
| Hypercalcemia | Serum calcium increased to >10.5 mg/dL | Assessed weekly for up to 4 weeks or until hypercalcemia develops |
| Hyperglycemia | Change in serum fructosamine | Assessed at baseline and at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
BMI > 99th percentile for age (<18 years) or BMI >35 kg/m2 (≥ 18 years)
Coexistent conditions that may affect calcium metabolism including:
History of diabetes related complications including:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
Data will be available in aggregate. No plan to share individual data at present.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorthalidone | Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorthalidone | Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Calcium Excretion | Change in 24 hour urine calcium excretion | Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported. | Posted | Assessed at baseline and at 4 weeks |
|
|
4 weeks
Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorthalidone | Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Dykes | University of Rochester | 15852750736 | carrie_dykes@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2017 | Dec 8, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D053565 | Hypercalciuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002752 | Chlorthalidone |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| Primary | Hypokalemia | Serum potassium decreased to <3.5 milliequivalent/L | Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported. | Posted | Assessed weekly for up to 4 weeks or until hypokalemia develops |
|
|
| Primary | Hypercalcemia | Serum calcium increased to >10.5 mg/dL | Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported. | Posted | Assessed weekly for up to 4 weeks or until hypercalcemia develops |
|
|
| Primary | Hyperglycemia | Change in serum fructosamine | Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported. | Posted | Assessed at baseline and at 4 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001577 | Benzophenones |
| D010797 | Phthalimides |
| D007094 | Imides |
| D007659 | Ketones |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |