RECRUITING

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

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Conditions

Type 1 DiabetesOsteopeniaBone LossFractures, BoneBoneCortical BoneMechanical Strength

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

Official Title

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Quick Facts

Study Start:2019-06-18
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701254

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. No chronic disease diagnoses that may affect bone, as confirmed by the PI.
  2. 2. Normal clinical history, physical, and clinical laboratory exam (except for usual complications of a 10+-year diabetic, i.e., \~minimal neuropathy or retinopathy, known, but asymptomatic mild vascular disease, etc.)
  3. 3. Glomelular Filtration Rate (GFR) \>45 ml/min (Renal Association lower limit for "mild" kidney failure).
  4. 4. Willingness to sign a consent form.
  5. 5. Willingness to undergo a transilial bone biopsy incision that yields 2 bone specimens.
  6. 6. No abnormalities in clinical blood chemistry measurements (small, age-related decreases in GFR, will be permitted).
  7. 7. Caucasian
  8. 1. Dual-energy x-ray absorptiometry (DXA) measures (BMD, gm/cm) must be within +/- 15% in total hip.
  9. 2. Body mass index (BMI) must be within +/-10%.
  10. 3. Age must be within +/- 5 years.
  11. 4. Caucasian
  1. 1. Women who have had Type 1 diabetes for less than 10 years.
  2. 2. Non-insulin dependent Type 1 diabetic.
  3. 3. Less than 50 years old.
  4. 4. Less than 5 years post menopausal.

Contacts and Locations

Study Contact

Adam Hornig
CONTACT
402-559-9116
adam.hornig@unmc.edu
Laura Armas, M.D.
CONTACT
402-559-8700
laura.armas@unmc.edu

Principal Investigator

Mohammed Akhter, PhD
PRINCIPAL_INVESTIGATOR
Creighton University Osteoporosis Research Center

Study Locations (Sites)

Creighton University Osteoporosis Research Center
Omaha, Nebraska, 68122
United States

Collaborators and Investigators

Sponsor: Creighton University

  • Mohammed Akhter, PhD, PRINCIPAL_INVESTIGATOR, Creighton University Osteoporosis Research Center

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 Registration Dates

Study Start Date2019-06-18
Study Completion Date2025-01

Study Record Updates

Study Start Date2019-06-18
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Bone
  • Cortical Bone
  • Mechanical Strength

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Osteopenia
  • Bone Loss
  • Fractures, Bone