Diabetes Mellitus, Type 1NCT03156179
Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by University of Rochester at 1 site in United States.
Trial summary
The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric… Read more about this study
- Who is it for?
- Ages 9 to 18 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- calcium isotope analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Teenage girls with type 1 diabetes.
Who may be able to join
- Diagnosis of T1D of at least three years duration
- Female sex
- Age between 9-18 years
- Parental/guardian consent and participant assent
- BMI <99th percentile
Who cannot join
- History of metabolic bone disease, chronic renal disease, hepatic disease, celiac, or other malabsorptive disease
- History of any proton-pump inhibitor use within a 6 month period prior to enrollment
- History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within a 6 month period prior to enrollment
- Pregnant or lactating females
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes
The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric populations.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- calcium isotope analysis
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium isotope analysisDiagnostic test
A dual stable calcium isotope method will be used to determine fractional calcium absorption. Two stable calcium isotopes will be administered to participants in order to determine fractional calcium absorption. 7 mg of 44Ca will be administered orally in 60 mL of liquid at the start of the study. 2 mg of 42Ca will then be administered intravenously. 24 hour urine collection will begin immediately following oral tracer administration for the assessment of urinary calcium excretion. The enrichment of 44Ca and 42Ca in urine will be determined by magnetic sector thermal ionization mass spectrometry. The isotopic ratios of 44Ca and 42Ca to 48Ca (another naturally occurring calcium isotope present in the human body) will be calculated (42Ca/48Ca and 44Ca/48Ca). The relative fraction of the oral to intravenously administered isotope in the 24 hour urine sample [(42Ca/48Ca) / (44Ca/48Ca)] is the fractional calcium absorption.
| Study group | Role | What they receive |
|---|---|---|
| Girls with type 1 diabetes | Not described Receives: Diagnostic Test: calcium isotope analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional calcium absorption
Mass spectroscopy was performed using urine to measure the stable calcium isotope. Percent dietary calcium absorption was calculated as the ratio of the cumulative recovery of 44Ca (oral tracer) to the cumulative recovery of 42Ca (IV tracer) in the 24-hour urine sample.
Measured: 24 hours
Secondary outcomes (1)
Estimated calcium retention
Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Sep 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Principal investigator, David Weber, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156179
- Sponsor's protocol ID
- 56744
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber DR, O'Brien KO, Schwartz GJ. Evidence of disordered calcium metabolism in adolescent girls with type 1 diabetes: An observational study using a dual-stable calcium isotope technique. Bone. 2017 Dec;105:184-190. doi: 10.1016/j.bone.2017.09.001. Epub 2017 Sep 4.
PubMed 28882565
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03156179
- Acronym / sponsor ID
- 56744
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric populations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Girls with type 1 diabetes | – | Diagnostic Test: calcium isotope analysis |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Teenage girls with type 1 diabetes.
Key inclusion criteria (5 listed)
- Diagnosis of T1D of at least three years duration
- Female sex
- Age between 9-18 years
- Parental/guardian consent and participant assent
- BMI <99th percentile
Key exclusion criteria (5 listed)
- History of metabolic bone disease, chronic renal disease, hepatic disease, celiac, or other malabsorptive disease
- History of any proton-pump inhibitor use within a 6 month period prior to enrollment
- History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within a 6 month period prior to enrollment
- Pregnant or lactating females
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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 |
|---|---|---|
| calcium isotope analysisA dual stable calcium isotope method will be used to determine fractional calcium absorption. Two stable calcium isotopes will be administered to participants in order to determine fractional calcium absorption. 7 mg of 44Ca will be administered orally in 60 mL of liquid at the start of the study. 2 mg of 42Ca will then be administered intravenously. 24 hour urine collection will begin immediately following oral tracer administration for the assessment of urinary calcium excretion. The enrichment of 44Ca and 42Ca in urine will be determined by magnetic sector thermal ionization mass spectrometry. The isotopic ratios of 44Ca and 42Ca to 48Ca (another naturally occurring calcium isotope present in the human body) will be calculated (42Ca/48Ca and 44Ca/48Ca). The relative fraction of the oral to intravenously administered isotope in the 24 hour urine sample [(42Ca/48Ca) / (44Ca/48Ca)] is the fractional calcium absorption. | Diagnostic test | Girls with type 1 diabetes |
Primary outcome
fractional calcium absorption
Time frame: 24 hours
Mass spectroscopy was performed using urine to measure the stable calcium isotope. Percent dietary calcium absorption was calculated as the ratio of the cumulative recovery of 44Ca (oral tracer) to the cumulative recovery of 42Ca (IV tracer) in the 24-hour urine sample.
1 secondary outcome
Estimated calcium retention
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 28882565Weber DR, O'Brien KO, Schwartz GJ. Evidence of disordered calcium metabolism in adolescent girls with type 1 diabetes: An observational study using a dual-stable calcium isotope technique. Bone. 2017 Dec;105:184-190. doi: 10.1016/j.bone.2017.09.001. Epub 2017 Sep 4.
- Individual participant dataSharing planned: No
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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?
An observational study of Diabetes Mellitus, Type 1, 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 5 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: finished, as of the sponsor's last update on 17 May 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fractional calcium absorption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156179, which also lists 1 linked publication.
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 17 May 2017.