B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

May 7, 2018 updated by: Rima Obeid, Universität des Saarlandes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • University of Saarland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female subjects with or without diabetes.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with type 2 diabetes
Patients (both men and women) with diagnosed type 2 Diabetes for at least 5 years. Blood collection and electrophysiological tests were performed.
Device: Blood collection and electrophysiological tests
Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.
Controls free of diabetes
Controls (both men and women) are people of the same age who are free of Diabetes. Blood collection and electrophysiological tests were performed.
Device: Blood collection and electrophysiological tests
Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Red blood cell cobalamin levels
Time Frame: Baseline
Baseline
Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma methylmalonic acid levels
Time Frame: Baseline
Baseline
Plasma choline levels
Time Frame: Baseline
Baseline
Plasma cobalamin levels
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Investigators

  • Principal Investigator: Rima Obeid, Dr., University Hospital of the Saarland, Department of Clinical Chemistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-vitamins polyneuropathy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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