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Non-Type 1 Diabetics for Broken Bones

N/A

Recruiting

Led By Mohammed Akhter, PhD

Research Sponsored by Creighton University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-8 weeks

Awards & highlights

Study Summary

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

Eligible Conditions

Broken Bones
Osteopenia
Osteoporosis
Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare cortical bone tissue levels of pentosidine (AGE), pyridinoline (normal enzymatic collagen crosslinks), and matrix-bound water between T1DM and controls.

Secondary outcome measures

Compare cortical bone tissue heterogeneity in nanoindentation measures of modulus and hardness between T1DM and controls.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Type 1 DiabeticsExperimental Treatment1 Intervention

All participants will complete 4 visits over 6-8 weeks. Visit 1 is a screening visit which includes a physical exam, a bone mineral density scan, a blood draw and an EKG. Visit 2 consists of dispensing the Tetracycline antibiotic required for the bone biopsy. Visit 3 is the bone biopsy and includes a blood draw. Visit 4 is to remove the stitches.

Group II: Non-Type 1 DiabeticsExperimental Treatment1 Intervention

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Who is running the clinical trial?

Creighton UniversityLead Sponsor

125 Previous Clinical Trials

25,616 Total Patients Enrolled

Mohammed Akhter, PhDPrincipal InvestigatorCreighton University Osteoporosis Research Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial actively recruiting participants?

"Affirmative. The information available on clinicaltrials.gov indicates that the trial, initially posted in June 2019, is currently recruiting patients - 80 participants across a single site to be precise. Additionally, it was most recently updated on January 17th 2023."

Answered by AI

How many participants are currently recruited for this research endeavor?

"Affirmative. According to the clinicaltrials.gov website, this medical study is actively recruiting candidates and has 80 openings across 1 site. The trial was originally published on June 18th 2019 and last updated on January 17th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701254.