Bone Health in Type 1 Diabetes (DMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00651196
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : March 18, 2013
Information provided by (Responsible Party):
Laura Armas, Creighton University

Brief Summary:
An increased skeletal fracture risk in diabetes has only recently been recognized. This human study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on structure.

Condition or disease
Type 1 Diabetes Osteoporosis

Detailed Description:
An increased skeletal fracture risk in diabetes has only recently been recognized. Human studies of patients with diabetes using bone mineral density and bone markers have noted low bone mass and mixed results on remodeling activity. Mouse models of diabetes have suggested that low bone turnover is the underlying problem. Low bone turnover could lead to an accumulation of microdamage that is not repaired causing compromised bone strength. Low bone turnover has not yet been confirmed in humans. This human study is designed to elucidate the effect of Type 1 diabetes on 1) bone remodeling, including histomorphometric and biochemical measures of bone formation and resorption, and 2) on structure, including micro architectural arrangement of trabeculae and bone mineral density.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pilot Study - Type 1 Diabetes and Bone Health
Study Start Date : January 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Type 1 diabetics
Healthy controls
Healthy age and sex matched controls

Primary Outcome Measures :
  1. histomorphometry measurements [ Time Frame: at 2nd visit ]

Secondary Outcome Measures :
  1. peripheral QCT measurements [ Time Frame: at 1st visit ]
  2. micro CT measurements [ Time Frame: at 2nd visit ]
  3. nanoindentation measurements [ Time Frame: at 2nd visit ]
  4. Bone mineral density [ Time Frame: at 1st visit ]

Biospecimen Retention:   Samples Without DNA
Transilial bone specimens are retained for measurements

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
males or females who are greater than 19 years of age and less than age 50 who have been diagnosed with type 1 diabetes for over 3 years.

Inclusion Criteria:

  • Age > 19 yrs or < 50 yrs.
  • The diabetic subjects must have a diagnosis of Type 1 diabetes clinically defined as diabetes onset before age 50, acute presentation or diabetic ketoacidosis, with normal BMI. If history is equivocal, GAD antibodies > 1.45 U/mL will be used to define diagnosis.
  • Diabetic subjects must be on insulin treatment.
  • All subjects must have BMI between 18-30

Exclusion Criteria:

  • On any medications that are known to interfere with bone metabolism including loop diuretics, steroids, anticonvulsants, bisphosphonates, metformin, glitazones
  • Have normal or only mildly impaired kidney function defined as a calculated GFR greater than 60 mL/min/1.73m2
  • History of cancer other than skin cancer
  • Unstable angina, myocardial infarction, uncontrolled hypertension, malabsorption, active rheumatoid or collagen disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00651196

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Laura A Armas, MD Creighton University

Responsible Party: Laura Armas, Assistant Professor, Creighton University Identifier: NCT00651196     History of Changes
Other Study ID Numbers: Creighton5
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Keywords provided by Laura Armas, Creighton University:
Type 1 diabetes

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