B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Universität des Saarlandes212 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

212

Conditions

Diabetes Complications

Interventions

Blood collection and electrophysiological testsDEVICE

Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Saarland

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

Red blood cell cobalamin levels

Time frame: Baseline

Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations

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.

Time frame: Baseline

Secondary Outcomes

Plasma methylmalonic acid levels

Time frame: Baseline

Plasma choline levels

Time frame: Baseline

Plasma cobalamin levels

Time frame: Baseline

Data from ClinicalTrials.gov

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