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NCT Number: NCT03156179

Study of Calcium Metabolism in Teenage 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

9 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Univeristy of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcium isotope analysis

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Estimated calcium retention

    Time frame: 24 hours

    Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Cornell University

Registry information

Official study title

Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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