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Type 1 Diabetes Mellitus Effect on Bone Mineral Density

Sponsor
Creighton University (Other)
Overall Status
Completed
CT.gov ID
NCT01633684
Collaborator
(none)
123
Enrollment
1
Location
23
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Because the diabetics are fracturing at a younger age than the general population (12), this leads us to believe there are significant factors that lead to fracture in Type 1 diabetes mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Because the diabetics are fracturing at a younger age than the general population(12), this leads us to believe there are significant factors that lead to fracture in Type 1 DM other than BMD. Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

    Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    123 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Type 1 DM Effect on BMD: a Longitudinal Study in Adults
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Diabetes

    patients with Type 1 Diabetes Mellitus
    Control

    Age and sex matched control subjects

    Outcome Measures

    Primary Outcome Measures

    1. Bone mineral Density [5 years]

      Bone mineral density will be measured yearly for 5 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • diabetic patients must have completed Visit 1 of the previous study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Creighton University

    Investigators

    • Principal Investigator: Laura Armas, MD,MS, Creighton University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Creighton University
    ClinicalTrials.gov Identifier:
    NCT01633684
    Other Study ID Numbers:
    • Creighton 14
    First Posted:
    Jul 4, 2012
    Last Update Posted:
    Oct 31, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Creighton University
    diabetes mellitus
    bone
    Additional relevant MeSH terms:
    Osteoporosis
    Diabetes Mellitus

    Study Results

    No Results Posted as of Oct 31, 2014