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B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02588898
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rima Obeid, 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.

Condition or disease Intervention/treatment
Diabetes Complications Device: Blood collection and electrophysiological tests

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

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Study Type : Observational
Actual Enrollment : 212 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
Study Start Date : September 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Plasma methylmalonic acid levels [ Time Frame: Baseline ]
  2. Plasma choline levels [ Time Frame: Baseline ]
  3. Plasma cobalamin levels [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
Fasting blood samples (serum, whole blood and EDTA-plasma)


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Male and female subjects with or without diabetes.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588898


Locations
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Germany
University of Saarland
Homburg, Saarland, Germany, 66424
Sponsors and Collaborators
Universität des Saarlandes
Investigators
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Principal Investigator: Rima Obeid, Dr. University Hospital of the Saarland, Department of Clinical Chemistry
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rima Obeid, Prof. (apl.) Dr., Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT02588898    
Other Study ID Numbers: B-vitamins polyneuropathy
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Polyneuropathies
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases