NCT01633684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

July 2, 2012

Last Update Submit

October 30, 2014

Conditions

Diabetes MellitusOsteoporosis

Keywords

diabetes mellitusbone

Outcome Measures

Primary Outcomes (1)

  • Bone mineral Density

    Bone mineral density will be measured yearly for 5 years

    5 years

Study Arms (2)

Diabetes

patients with Type 1 Diabetes Mellitus

Control

Age and sex matched control subjects

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be storing serum samples. No genetic tests will be performed on these.

MeSH Terms

Conditions

Diabetes MellitusOsteoporosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Study Officials

  • Laura Armas, MD,MS

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 4, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

US(1)