B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
Completed
- Conditions
- Diabetes Complications
- 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.
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
- 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
University of Saarland🇩🇪Homburg, Saarland, Germany