Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03156179|
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1||Diagnostic Test: calcium isotope analysis|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
|Girls with type 1 diabetes||
Diagnostic Test: calcium isotope analysis
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.
- 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.
- Estimated calcium retention [ Time Frame: 24 hours ]Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156179
|United States, New York|
|Univeristy of Rochester Medical Center|
|Rochester, New York, United States, 14642|