Status:
COMPLETED
Bone Health in Type 1 Diabetes
Lead Sponsor:
Creighton University
Conditions:
Type 1 Diabetes
Osteoporosis
Eligibility:
All Genders
19-50 years
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.
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 mixe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00651196
Start Date
January 1 2008
End Date
January 1 2013
Last Update
March 18 2013
Active Locations (1)
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1
Creighton University
Omaha, Nebraska, United States, 68131