Bone Health in Type 1 Diabetes

NCT ID: NCT00651196

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Type 1 Diabetes; Osteoporosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

Type 1 diabetics

No interventions assigned to this group

Healthy controls

Healthy age and sex matched controls

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Laura Armas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura A Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

Creighton5

Identifier Type: -

Identifier Source: org_study_id