Type 1 Diabetes Mellitus Effect on Bone Mineral Density

October 30, 2014 updated by: Creighton University

Type 1 DM Effect on BMD: a Longitudinal Study in Adults

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have Type 1 DM and their age and sex matched control and have been enrolled in a study of Type 1 DM and bone and had a baseline DXA and pQCT during the last 4 years. Persons that completed visit 1 for the previous study and had a DXA and pQCT done will be invited back for repeat DXA and pQCT measurement. If a diabetic patient does not have an age and sex matched control or their control does not want to be in the longitudinal study a new age and sex matched control will be recruited.

Description

Inclusion Criteria:

  • diabetic patients must have completed Visit 1 of the previous study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetes
patients with Type 1 Diabetes Mellitus
Control
Age and sex matched control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral Density
Time Frame: 5 years
Bone mineral density will be measured yearly for 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Creighton 14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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