B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

NCT ID: NCT02588898

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-01-31

Brief Summary

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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

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

Conditions

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Diabetes Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Blood collection and electrophysiological tests

Intervention Type DEVICE

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.

Blood collection and electrophysiological tests

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Rima Obeid

Prof. (apl.) Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rima Obeid, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of the Saarland, Department of Clinical Chemistry

Locations

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University of Saarland

Homburg, Saarland, Germany

Site Status

Countries

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Germany

References

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Obeid R, Jung J, Falk J, Herrmann W, Geisel J, Friesenhahn-Ochs B, Lammert F, Fassbender K, Kostopoulos P. Serum vitamin B12 not reflecting vitamin B12 status in patients with type 2 diabetes. Biochimie. 2013 May;95(5):1056-61. doi: 10.1016/j.biochi.2012.10.028. Epub 2012 Nov 17.

Reference Type RESULT
PMID: 23168250 (View on PubMed)

Obeid R, Awwad HM, Rabagny Y, Graeber S, Herrmann W, Geisel J. Plasma trimethylamine N-oxide concentration is associated with choline, phospholipids, and methyl metabolism. Am J Clin Nutr. 2016 Mar;103(3):703-11. doi: 10.3945/ajcn.115.121269. Epub 2016 Feb 10.

Reference Type DERIVED
PMID: 26864355 (View on PubMed)

Other Identifiers

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B-vitamins polyneuropathy

Identifier Type: -

Identifier Source: org_study_id

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