Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Girls with type 1 diabetes

calcium isotope analysis

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No