Diabetes, Falls, and Fractures

Completed

• Conditions: Small Fiber Neuropathy; Diabetic Peripheral Neuropathy; Vestibular Neuropathy; Autonomic Neuropathy, Diabetic; Balance; Distorted; Muscle Weakness; Sarcopenia; Diabetes

• Registration Number: NCT05389566
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-06
• Study First Submitted: 2022-05-06
• Primary Completion: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Completion: 2022-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Men and women with minimum 40 years of age and maximum 70 years of age.
2. Diagnosis of T1D or T2D
3. Diagnosis of diabetes with at least one year prior to inclusion of the study
4. Signed the informed consent.

Exclusion Criteria

1. Severe decreased liver function (Alanin amino-transaminase (ALAT)>250u/l, GammaGlutamyltransferase (GGT)>150u/l)

2. Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15mmol/L/1,73m2

3. Pregnancy or breast feeding

4. Active malignancy or terminal ill.

5. Current or previous alcohol- or drug abuse

6. Not being able to understand Danish written and/or verbally 9. Terms according to investigators judgement that makes subjects unsuitable to participate including lack of understanding or reduced physical ability. 10. Participating in other clinical studies 11. Maximum of 10 hours of weekly exercise.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Co-existence of peripheral- and vestiubular neuropathy in people with diabetes	through study completion, an average of 2 years	Vestibular neuropathy (measured by pathological video head impulse test (v-Hit) (one-sided, two-sided or specific arcways)) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.
Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes	through study completion, an average of 2 years	Dynamic balance (measured by Bertec) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.

Secondary Outcome Measures

Name	Time	Method
Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy	through study completion, an average of 2 years	QST / NC-Stat DPNCheck vs v-Hit
The impact of peripheral neuropathy on postural control (In quite stance)	through study completion, an average of 2 years	QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate
Correlation between distal neuropathy and dynamic postural control (including patterns)	through study completion, an average of 2 years	QST / NC-Stat DPNCheck vs accelerometer / Bertec

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark