- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03156179
Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes
May 15, 2017 updated by: David Weber, University of Rochester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642
- Univeristy of Rochester Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Teenage girls with type 1 diabetes.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Girls with type 1 diabetes
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fractional calcium absorption
Time Frame: 24 hours
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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.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated calcium retention
Time Frame: 24 hours
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Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.
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24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
May 15, 2017
First Submitted That Met QC Criteria
May 15, 2017
First Posted (Actual)
May 17, 2017
Study Record Updates
Last Update Posted (Actual)
May 17, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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