Clinical trial NCT05389566: Diabetes, Falls, and Fractures
Official title: Diabetes, Falls, and Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Diabetes
Balance; Distorted
Vestibular Neuropathy
Muscle Weakness
Sarcopenia
Autonomic Neuropathy, Diabetic
Small Fiber Neuropathy
Keywords: Diabetes
Balance
Vestibular
Neuropathy
Muscle Weakness
Autonomic Neuropathy
Small Fiber Neuropathy
Postural control
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-05-25
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark

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


Eligibility criteria: 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.

Primary outcomes:
measure: Co-existence of peripheral- and vestiubular neuropathy in people with diabetes
timeFrame: through study completion, an average of 2 years
measure: Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy
timeFrame: through study completion, an average of 2 years
measure: Correlation between distal neuropathy and dynamic postural control (including patterns)
timeFrame: through study completion, an average of 2 years
measure: The impact of peripheral neuropathy on postural control (In quite stance)
timeFrame: through study completion, an average of 2 years
Other outcomes:
measure: Exploratory
timeFrame: through study completion, an average of 2 years
measure: Exploratory
timeFrame: through study completion, an average of 2 years
measure: Muscle strength and peripheral neuropathy
timeFrame: through study completion, an average of 2 years
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
References: