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Type 1 Diabetes Mellitus Effect on Bone Mineral Density

NCT ID: NCT01633684

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus Osteoporosis

Keywords

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diabetes mellitus bone

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

patients with Type 1 Diabetes Mellitus

No interventions assigned to this group

Control

Age and sex matched control subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diabetic patients must have completed Visit 1 of the previous study.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Armas, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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Creighton 14

Identifier Type: -

Identifier Source: org_study_id