Diabetes, Falls, and Fractures

Diabetes Clinical Trial

— DIAFALL  

Official title:

Diabetes, Falls, and Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389566
• Other study ID #: N-20190004
• Status: Recruiting
• Start date: May 6, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2022
• Source: Aalborg University Hospital
• Contact: Nicklas H Rasmussen, PhD
• Phone: 97663651
• Email: nicklas.rasmussen[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 1, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

8. 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.

Related Conditions & MeSH terms

• Autonomic Neuropathy, Diabetic
• Balance; Distorted
• Diabetes
• Diabetes Mellitus
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Muscle Weakness
• Paresis
• Peripheral Nervous System Diseases
• Sarcopenia
• Small Fiber Neuropathy
• Vestibular Neuronitis
• Vestibular Neuropathy

Intervention

Diagnostic Test:
• Quantative Sensory Testing
Evaluation of small fiber neuropathy
• NCStat-DPN-Check
Evaluation of large fiber neuropathy
• Composite Autonomic Symptom Score 31
Evaluation of autonomic neuropathy
• Computerized dynamic posturography
Evaluation of dynamic postural control
• Video Head Impulse Test
Evaluation of vertigo and the vestibular organ
• Accelerometer
Evaluation of gait pattern
• Handgrip strength
Evaluation of muscle strength
• Dual Energy X-ray Absorbtimetry scan
Evaluation of body composition
• Force Plate Platform
Evaluation of balance while standing still

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory	accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking)	through study completion, an average of 2 years
Other	Exploratory	Correlations between different outcomes of Bertec and v-Hit vs peripheral neuropathy (all individual examinations and arcways)	through study completion, an average of 2 years
Other	Muscle strength and peripheral neuropathy	Correlation between muscle strength and peripheral neuropathy (DEXA-scans, hand grup strength, QST, Correlation between muscle strength and peripheral neuropathy	through study completion, an average of 2 years
Primary	Co-existence of peripheral- and vestiubular neuropathy in people with diabetes	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.	through study completion, an average of 2 years
Primary	Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes	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.	through study completion, an average of 2 years
Secondary	Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy	QST / NC-Stat DPNCheck vs v-Hit	through study completion, an average of 2 years
Secondary	Correlation between distal neuropathy and dynamic postural control (including patterns)	QST / NC-Stat DPNCheck vs accelerometer / Bertec	through study completion, an average of 2 years
Secondary	The impact of peripheral neuropathy on postural control (In quite stance)	QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate	through study completion, an average of 2 years