A Phase 2 interventional study of Chlorthalidone in Type 1 Diabetes Mellitus and Hypercalciuria, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by University of Rochester · Phase 2, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Coexistent conditions that may affect calcium metabolism including:
History of diabetes related complications including:
Laboratory abnormalities on screening bloodwork including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
Drug: Chlorthalidone
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Urinary Calcium Excretion
Change in 24 hour urine calcium excretion
Time frame: Assessed at baseline and at 4 weeks
Hypokalemia
Serum potassium decreased to \<3.5 milliequivalent/L
Time frame: Assessed weekly for up to 4 weeks or until hypokalemia develops
Hypercalcemia
Serum calcium increased to \>10.5 mg/dL
Time frame: Assessed weekly for up to 4 weeks or until hypercalcemia develops
Hyperglycemia
Change in serum fructosamine
Time frame: Assessed at baseline and at 4 weeks
| Milestone | Chlorthalidone |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
Change in 24 hour urine calcium excretion
No measurements were reported for this outcome.
Serum potassium decreased to \<3.5 milliequivalent/L
No measurements were reported for this outcome.
Serum calcium increased to \>10.5 mg/dL
No measurements were reported for this outcome.
Change in serum fructosamine
No measurements were reported for this outcome.
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chlorthalidone | — | — | — |
Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
| Age, Categorical | Chlorthalidone |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | Chlorthalidone |
|---|
| Sex: Female, Male | Chlorthalidone |
|---|---|
| Female | — |
| Male | — |
| Race (NIH/OMB) | Chlorthalidone |
|---|---|
| American Indian or Alaska Native | — |
| Asian | — |
| Native Hawaiian or Other Pacific Islander | — |
| Black or African American | — |
| White | — |
| More than one race | — |
| Unknown or Not Reported | — |
| Region of Enrollment(participants) | Chlorthalidone |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data will be available in aggregate. No plan to share individual data at present.
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorthalidone