The effects of nerve dysfunction upon blood vessels in diabetes.

Not Applicable

• Conditions: Diabetes; Diabetic neuropathy; Peripheral Arterial Disease; Neurological - Other neurological disorders; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618001370291
• Lead Sponsor: niversity of New England

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-15
• Study Completion: 2020-03-12
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Type 2 diabetic participants, with or without diabetic neuropathy

Exclusion Criteria

Inability to provide informed consent
Pregnancy, breastfeeding
Proliferative diabetic retinopathy (or no eye examination within preceding 12 months)
Hypocalcaemia
Smoker within previous 12 months
Chronic atrial flutter or fibrillation
Bleeding disorders, warfarin (or equivalent) therapy
Anti-VEGF therapy
Lymphoedema or known vascular abnormality in upper limbs
Previous or current DVT
Severe systolic hypertension (>180mmHg)
Haematological malignancy
Recent severe acute illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in plasma levels of vascular endothelial growth factor in peripheral venous blood (ELISA assay)[Measured at baseline immediately prior to intervention, then 15 and 60 minutes (primary endpoint) after intervention. ];Change in serum levels of apolipoprotein A-1 in peripheral venous blood.[Measured at baseline immediately prior to intervention, then 15 (primary endpoint) and 60 minutes after intervention. ];Change in plasma levels of calcitonin gene-related peptide in peripheral venous blood (ELISA assay)[Measured at baseline immediately prior to intervention, then 15 (primary endpoint) and 60 minutes after intervention. ]

Secondary Outcome Measures

Name	Time	Method
Change in serum C reactive protein in peripheral venous blood[Measured at baseline immediately prior to intervention, then 15 and 60 minutes after intervention,];Changes in heart rate variability assessed with use of an ambulatory Holter monitor[Measured immediately prior to, during and 24 hours after the intervention, with continuous ambulatory monitoring. ];Changes in arterial blood pressure (mmHg) using non-invasive continuous blood pressure monitoring of the dominant arm, measured by Finometer® Midi Model-2 (Finapres Medical Systems B.V., Amsterdam, The Netherlands)[Measured continuously from 10 minutes prior to intervention until 10 minutes after final cuff deflation.];Change in serum glucose in peripheral venous blood[Measured at baseline immediately prior to intervention, then 15 and 60 minutes after intervention. This is a possible confounding variable that might be part of secondary analysis to identify confounding factors.]