Bone Health in Type 1 Diabetes

NCT00651196 | Completed

• 1 other identifier: Creighton5
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Osteoporosis

Keywords

Type 1 diabetes; bone

Outcome Measures

Primary Outcomes (1)

• histomorphometry measurements

  at 2nd visit

Secondary Outcomes (4)

• peripheral QCT measurements

  at 1st visit

• micro CT measurements

  at 2nd visit

• nanoindentation measurements

  at 2nd visit

• Bone mineral density

  at 1st visit

Study Arms (2)

1

Type 1 diabetics

Healthy controls

Healthy age and sex matched controls

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

males or females who are greater than 19 years of age and less than age 50 who have been diagnosed with type 1 diabetes for over 3 years.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Transilial bone specimens are retained for measurements

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Osteoporosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Laura A Armas, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 2, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

US (1)