Type 1 Diabetes Clinical Trial
— DMBOfficial title:
Pilot Study - Type 1 Diabetes and Bone Health
Verified date | March 2013 |
Source | Creighton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 50 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Creighton University | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Creighton University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | histomorphometry measurements | at 2nd visit | No | |
Secondary | peripheral QCT measurements | at 1st visit | No | |
Secondary | micro CT measurements | at 2nd visit | No | |
Secondary | nanoindentation measurements | at 2nd visit | No | |
Secondary | Bone mineral density | at 1st visit | No |
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