B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
1 other identifier
observational
212
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedMay 11, 2018
May 1, 2018
1.3 years
October 21, 2015
May 7, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Red blood cell cobalamin levels
Baseline
Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigations
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 Outcomes (3)
Plasma methylmalonic acid levels
Baseline
Plasma choline levels
Baseline
Plasma cobalamin levels
Baseline
Study Arms (2)
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.
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.
Interventions
Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.
Eligibility Criteria
Male and female subjects with or without diabetes.
You may qualify if:
- Male and female subjects with or without diabetes.
You may not qualify if:
- Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
- Liver or renal dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saarland
Homburg, Saarland, 66424, Germany
Related Publications (2)
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.
PMID: 23168250RESULTObeid 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.
PMID: 26864355DERIVED
Biospecimen
Fasting blood samples (serum, whole blood and EDTA-plasma)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rima Obeid, Dr.
University Hospital of the Saarland, Department of Clinical Chemistry
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. (apl.) Dr.
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 28, 2015
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 11, 2018
Record last verified: 2018-05