Diabetes, Falls, and Fractures (DIAFALL)

Aalborg University Hospital

Status: Completed

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

Treatments: Diagnostic Test: Accelerometer; Diagnostic Test: Video Head Impulse Test; Diagnostic Test: Composite Autonomic Symptom Score 31; Diagnostic Test: Quantative Sensory Testing; Diagnostic Test: Computerized dynamic posturography; Diagnostic Test: Handgrip strength; Diagnostic Test: Dual Energy X-ray Absorbtimetry scan; Diagnostic Test: NCStat-DPN-Check; Diagnostic Test: Force Plate Platform

Study type: Observational

Funder types: Other

Identifiers

NCT05389566

N-20190004

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

110 participants in 3 patient groups

Type 1 diabetes

Description:

People with type 1 diabetes above 40 years

Treatment:

Diagnostic Test: Force Plate Platform

Diagnostic Test: NCStat-DPN-Check

Diagnostic Test: Dual Energy X-ray Absorbtimetry scan

Diagnostic Test: Handgrip strength

Diagnostic Test: Computerized dynamic posturography

Diagnostic Test: Quantative Sensory Testing

Diagnostic Test: Composite Autonomic Symptom Score 31

Diagnostic Test: Accelerometer

Diagnostic Test: Video Head Impulse Test

People with type 2 diabetes

Description:

People with type 2 diabetes above 50 years

Treatment:

Diagnostic Test: Force Plate Platform

Diagnostic Test: NCStat-DPN-Check

Diagnostic Test: Dual Energy X-ray Absorbtimetry scan

Diagnostic Test: Handgrip strength

Diagnostic Test: Computerized dynamic posturography

Diagnostic Test: Quantative Sensory Testing

Diagnostic Test: Composite Autonomic Symptom Score 31

Diagnostic Test: Accelerometer

Diagnostic Test: Video Head Impulse Test

Healthy controls

Description:

Healthy controls without diabetes

Treatment:

Diagnostic Test: Force Plate Platform

Diagnostic Test: NCStat-DPN-Check

Diagnostic Test: Dual Energy X-ray Absorbtimetry scan

Diagnostic Test: Handgrip strength

Diagnostic Test: Computerized dynamic posturography

Diagnostic Test: Quantative Sensory Testing

Diagnostic Test: Composite Autonomic Symptom Score 31

Diagnostic Test: Accelerometer

Diagnostic Test: Video Head Impulse Test