Diabetic peripheral neuropathy Nutritional, Metabolic, Endocrine
Conditions
Interventions
Screening Visit:
People with type 2 diabetes attending the Sheffield One-Stop Screening Service in both community and hospital settings will be invited and consented to participate in the screening ph
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: For screening: 1. People with T2D 2. Age 18-75 years 3. HbA1c >8.0% (64 mmol/mol) For the trial: 1. People with T2D 2. Age 18-75 years 3. HbA1c >8.5% (69 mmol/mol) 4. Normal/mildly abnormal mTCNS 5. Have detectable DPNCheck SA (>1 mV) 6. Abnormal DPN-Check SNCV or amplitude for age (based on age-related normative values) 7. Willing and able to comply with the study schedule and be available for the treatment duration 8. Able to give written informed consent
Exclusion criteria
Exclusion criteria: For the trial: 1. Diagnosis with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes (MODY), gestational diabetes or latent autoimmune diabetes in adults (LADA) 2. Housebound 3. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement 4. Active psychotic illness 5. Current pregnancy, or actively trying to conceive 6. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease) 7. Requirement for renal replacement therapy 8. Planned major surgery over the duration of the trial 9. Alcohol/substance abuse 10. Patients taking part in any other clinical trials or observational research that will interfere with the delivery of this trial protocol or overburden the patient 11. Unwilling or unable to give informed consent to participate in the study 12. Any other conditions, which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nerve damage is measured using sural nerve action potential (SNAP; obtained by conventional electrophysiology) at baseline and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Small- and large-fibre dysfunction measured using skin intraepidermal nerve density, peripheral neurological examination, and quantitative sensory testing at baseline and 24 months 2. The diagnostic accuracy of the point-of-care devices (DPN-Check and Sudoscan) of diabetic peripheral neuropathy will be measured against the gold standard SNAP at baseline and 24 months 3. Cardiometabolic risk factors and quality of life are measured using patient-related outcomes, biomedical markers, and anthropometric parameters at baseline and 24 months | — |
Countries
England, United Kingdom
Contacts
Public ContactSharon Caunt
Outcome results
None listed