B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Completed

• Conditions: Diabetes Complications
• Interventions: Device: Blood collection and electrophysiological tests

• Registration Number: NCT02588898
• Lead Sponsor: Universität des Saarlandes

Brief Summary

This case-control study investigated B-vitamin and homocysteine in relation to the presence or the absence of type 2 diabetes and clinical signs of polyneuropathy.

Detailed Description

Blood samples were collected and clinical investigations were performed at the same time.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Male and female subjects with or without diabetes.

Exclusion Criteria

• Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
• Liver or renal dysfunction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes	Blood collection and electrophysiological tests	Patients (both men and women) with diagnosed type 2 Diabetes for at least 5 years. Blood collection and electrophysiological tests were performed.
Controls free of diabetes	Blood collection and electrophysiological tests	Controls (both men and women) are people of the same age who are free of Diabetes. Blood collection and electrophysiological tests were performed.

Primary Outcome Measures

Name	Time	Method
Red blood cell cobalamin levels	Baseline
Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations	Baseline	Polyneuropathy grade was accessed using a questionnaire and a clinical examination (electrophysiology) after nerve stimulation. A score includes the combination of questionnaire data and electrophysiology data.

Secondary Outcome Measures

Name	Time	Method
Plasma choline levels	Baseline
Plasma methylmalonic acid levels	Baseline
Plasma cobalamin levels	Baseline

Trial Locations

Locations (1)

University of Saarland; 🇩🇪 Homburg, Saarland, Germany