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NCT01633684 Clinical Trial

Type 1 Diabetes Mellitus Effect on Bone Mineral Density

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01633684
Other study ID # Creighton 14
Secondary ID
Status Completed
Phase N/A
First received July 2, 2012
Last updated October 30, 2014
Start date August 2012
Est. completion date July 2014

Study information
Verified date October 2014
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Creighton University Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral Density Bone mineral density will be measured yearly for 5 years 5 years No
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