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Type 1 Diabetes Mellitus Effect on Bone Mineral Density

This study is not yet open for participant recruitment.
Verified July 2012 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01633684
First received: July 2, 2012
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Diabetes Mellitus
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Type 1 DM Effect on BMD: a Longitudinal Study in Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Bone mineral Density [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Bone mineral density will be measured yearly for 5 years


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes
patients with Type 1 Diabetes Mellitus
Control
Age and sex matched control subjects

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • diabetic patients must have completed Visit 1 of the previous study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633684

Contacts
Contact: Julie Stubby, RN 402-280-4958 jas@creighton.edu
Contact: Laura AG Armas 402-280-4470 larmas@creighton.edu

Locations
United States, Nebraska
Creighton University Not yet recruiting
Omaha, Nebraska, United States, 68131
Contact: Julie Stubby, RN     402-280-4958     jas@creighton.edu    
Contact: Laura Armas     402-280-4470     larmas@creighton.edu    
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Laura Armas, MD,MS Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01633684     History of Changes
Other Study ID Numbers: Creighton 14
Study First Received: July 2, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
diabetes mellitus
bone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Osteoporosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013