Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Diagnostic Test: calcium isotope analysis

• Registration Number: NCT03156179
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Girls with type 1 diabetes	calcium isotope analysis	-

Primary Outcome Measures

Name	Time	Method
fractional calcium absorption	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.

Secondary Outcome Measures

Name	Time	Method
Estimated calcium retention	24 hours	Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.

Trial Locations

Locations (1)

Univeristy of Rochester Medical Center; 🇺🇸 Rochester, New York, United States