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Completed

NCT Number: NCT02588898

B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Saarland

Homburg, Saarland, 66424, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood collection and electrophysiological tests

Device

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

Primary outcomes

  1. Red blood cell cobalamin levels

    Time frame: Baseline

  2. 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.

Secondary outcomes

  1. Plasma methylmalonic acid levels

    Time frame: Baseline

  2. Plasma choline levels

    Time frame: Baseline

  3. Plasma cobalamin levels

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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