Type 1 Diabetes MellitusPhase 2NCT03325114
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
A Phase 2 study testing Chlorthalidone in people with Type 1 Diabetes Mellitus and Hypercalciuria, run by University of Rochester at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypercalciuria
- What is being tested?
- Chlorthalidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 1 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
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
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Hypercalciuria
- Being tested
- Chlorthalidone
- Keywords
- type 1 diabetes, hypercalciuria
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorthalidoneDrug
Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chlorthalidone | Other | Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Receives: Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Calcium Excretion
Change in 24 hour urine calcium excretion
Measured: Assessed at baseline and at 4 weeks
Hypokalemia
Serum potassium decreased to <3.5 milliequivalent/L
Measured: Assessed weekly for up to 4 weeks or until hypokalemia develops
Hypercalcemia
Serum calcium increased to >10.5 mg/dL
Measured: Assessed weekly for up to 4 weeks or until hypercalcemia develops
Hyperglycemia
Change in serum fructosamine
Measured: Assessed at baseline and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start28 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: COVID restrictions prohibit further study activies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325114
- Sponsor's protocol ID
- 66282
- Other IDs
- 1K23DK114477-01
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available in aggregate. No plan to share individual data at present.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03325114
- Acronym / sponsor ID
- 66282
- Conditions
- Type 1 Diabetes Mellitus, Hypercalciuria
- Keywords
- type 1 diabetes, hypercalciuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID restrictions prohibit further study activies
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chlorthalidone | Other | Drug: ChlorthalidoneChlorthalidone 12.5-50 mg by mouth daily for 4 weeks |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorthalidoneChlorthalidone 12.5-5 mg by mouth daily for 4 weeks | Drug | Chlorthalidone |
Primary outcome
Urinary Calcium Excretion
Time frame: Assessed at baseline and at 4 weeks
Change in 24 hour urine calcium excretion
Hypokalemia
Time frame: Assessed weekly for up to 4 weeks or until hypokalemia develops
Serum potassium decreased to <3.5 milliequivalent/L
Hypercalcemia
Time frame: Assessed weekly for up to 4 weeks or until hypercalcemia develops
Serum calcium increased to >10.5 mg/dL
Hyperglycemia
Time frame: Assessed at baseline and at 4 weeks
Change in serum fructosamine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be available in aggregate. No plan to share individual data at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorthalidone in people with Type 1 Diabetes Mellitus and Hypercalciuria, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Calcium Excretion (time frame: Assessed at baseline and at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.