Bone Health in Type 1 Diabetes (DMB)

March 14, 2013 updated by: Laura Armas, Creighton University

Pilot Study - Type 1 Diabetes and Bone Health

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Type 1 diabetics
Healthy controls
Healthy age and sex matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
histomorphometry measurements
Time Frame: at 2nd visit
at 2nd visit

Secondary Outcome Measures

Outcome Measure
Time Frame
peripheral QCT measurements
Time Frame: at 1st visit
at 1st visit
micro CT measurements
Time Frame: at 2nd visit
at 2nd visit
nanoindentation measurements
Time Frame: at 2nd visit
at 2nd visit
Bone mineral density
Time Frame: at 1st visit
at 1st visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 30, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Creighton5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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