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Completed

NCT Number: NCT00651196

Bone Health in Type 1 Diabetes

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. histomorphometry measurements

    Time frame: at 2nd visit

Secondary outcomes

  1. peripheral QCT measurements

    Time frame: at 1st visit

  2. micro CT measurements

    Time frame: at 2nd visit

  3. nanoindentation measurements

    Time frame: at 2nd visit

  4. Bone mineral density

    Time frame: at 1st visit

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

Pilot Study - Type 1 Diabetes and Bone Health

Acronym: DMB

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2008
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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