Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156179
• Other study ID #: 56744
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 15, 2017
• Start date: September 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	Estimated calcium retention	Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.	24 hours