Actively Recruiting

Age: 50Years +
FEMALE
Healthy Volunteers
NCT05701254

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

Led by Creighton University · Updated on 2024-09-25

80

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients with Type 1 Diabetes Mellitus
  • Age 50 years or older
  • Postmenopausal for at least 5 years
  • Have had diabetes for more than 10 years
  • No chronic diseases affecting bone as confirmed by the investigator
  • Normal clinical history, physical exam, and laboratory results except for typical mild diabetic complications
  • Glomerular Filtration Rate (GFR) greater than 45 ml/min
  • Willing to sign consent and undergo transiliac bone biopsy
  • Caucasian
  • For non-diabetic controls: matched to diabetic participant within +/- 15% hip bone density, +/- 10% BMI, and +/- 5 years age
  • Caucasian
Not Eligible

You will not qualify if you...

  • Women with Type 1 Diabetes for less than 10 years
  • Non-insulin dependent Type 1 Diabetes
  • Younger than 50 years old
  • Less than 5 years postmenopausal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Creighton University Osteoporosis Research Center

Omaha, Nebraska, United States, 68122

Actively Recruiting

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Research Team

A

Adam Hornig

CONTACT

L

Laura Armas, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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