Text Size

Bone Health in Type 1 Diabetes (DMB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Armas, Creighton University
ClinicalTrials.gov Identifier:
NCT00651196
First received: March 30, 2008
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Type 1 Diabetes
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pilot Study - Type 1 Diabetes and Bone Health

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • histomorphometry measurements [ Time Frame: at 2nd visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • peripheral QCT measurements [ Time Frame: at 1st visit ] [ Designated as safety issue: No ]
  • micro CT measurements [ Time Frame: at 2nd visit ] [ Designated as safety issue: No ]
  • nanoindentation measurements [ Time Frame: at 2nd visit ] [ Designated as safety issue: No ]
  • Bone mineral density [ Time Frame: at 1st visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Transilial bone specimens are retained for measurements


Estimated Enrollment: 60
Study Start Date: January 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Type 1 diabetics
Healthy controls
Healthy age and sex matched controls

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.

  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

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651196

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

No publications provided

Responsible Party: Laura Armas, Assistant Professor, Creighton University
ClinicalTrials.gov Identifier: NCT00651196     History of Changes
Other Study ID Numbers: Creighton5
Study First Received: March 30, 2008
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Type 1 diabetes
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 16, 2013