Bone Health in Type 1 Diabetes - Full Text View

Sponsored by:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00651196

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:	Case Control, Cross-Sectional
Official Title:	Pilot Study - Type 1 Diabetes and Bone Health

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Osteoporosis

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

Biospecimen Description:

Transilial bone specimens are retained for measurements

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2013
Estimated 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

Contacts

Contact: Laura A Armas, MD

402-280-4676

larmas@creighton.edu

Locations

United States, Nebraska
Creighton University	Recruiting
Omaha, Nebraska, United States, 68131
Contact: Julie Stubby, RN 402-280-4958 jstubby@creighton.edu
Contact: Laura Armas, MD 402-280-4676 larmas@creighton.edu
Sub-Investigator: Robert R Recker, MD
Principal Investigator: Laura Armas, MD

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Laura A Armas, MD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Laura Armas )
Study ID Numbers:	Creighton5
Study First Received:	March 30, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00651196 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Type 1 diabetes
bone

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Osteoporosis
Endocrine System Diseases
Bone Diseases, Metabolic
Diabetes Mellitus Type 1

Bone Diseases
Diabetes Mellitus, Type 1
Musculoskeletal Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Musculoskeletal Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Osteoporosis
Bone Diseases, Metabolic
Glucose Metabolism Disorders
Bone Diseases

ClinicalTrials.gov processed this record on September 11, 2009