DMB: Bone Health in Type 1 Diabetes

• Sponsor: Creighton University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00651196
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Osteoporosis

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 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Pilot Study - Type 1 Diabetes and Bone Health
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
1 Type 1 diabetics
Healthy controls Healthy age and sex matched controls

Outcome Measures

Primary Outcome Measures

1. histomorphometry measurements [at 2nd visit]

Secondary Outcome Measures

1. peripheral QCT measurements [at 1st visit]

2. micro CT measurements [at 2nd visit]

3. nanoindentation measurements [at 2nd visit]

4. Bone mineral density [at 1st visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Creighton University	Omaha	Nebraska	United States	68131

Sponsors and Collaborators

• Creighton University

Investigators

• Principal Investigator: Laura A Armas, MD, Creighton University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Armas, Assistant Professor, Creighton University
• ClinicalTrials.gov Identifier: NCT00651196
• Other Study ID Numbers: Creighton5
• First Posted: Apr 2, 2008
• Last Update Posted: Mar 18, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Laura Armas, Assistant Professor, Creighton University: Type 1 diabetes; bone
• Additional relevant MeSH terms: Osteoporosis; Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Mar 18, 2013