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Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03156179
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Cornell University
Information provided by (Responsible Party):
David Weber, 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Diagnostic Test: calcium isotope analysis

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Estimated calcium retention [ Time Frame: 24 hours ]
    Gastrointestinal calcium absorption minus the total of urine calcium excretion and estimated stool calcium excretion.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females has an increased risk of bone fractures.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Teenage girls with type 1 diabetes.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03156179

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United States, New York
Univeristy of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Cornell University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Weber, Assistant Professor, University of Rochester Identifier: NCT03156179    
Other Study ID Numbers: 56744
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs