Bone Health in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— DMB  

Official title:

Pilot Study - Type 1 Diabetes and Bone Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651196
• Other study ID #: Creighton5
• Status: Completed
• Phase: N/A
• First received: March 30, 2008
• Last updated: March 14, 2013
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Osteoporosis
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

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