Bone Health in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study - Type 1 Diabetes and Bone Health

Conditions
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Type 1 Diabetes, Osteoporosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Type 1 diabetics | |
| Healthy controls<br>Healthy age and sex matched controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histomorphometry measurements |  | at 2nd visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral QCT measurements |  | at 1st visit | 
| micro CT measurements |  | at 2nd visit | 
| nanoindentation measurements |  | at 2nd visit | 
| Bone mineral density |  | at 1st visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, bone