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Clinical Trials/NCT02588898
NCT02588898CompletedNot Applicable

B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Universität des Saarlandes1 site in 1 country212 target enrollmentStarted: September 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
212
Locations
1
Primary Endpoint
Red blood cell cobalamin levels
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Red blood cell cobalamin levels

Time Frame: 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.

Secondary Outcomes

  • Plasma choline levels(Baseline)
  • Plasma methylmalonic acid levels(Baseline)
  • Plasma cobalamin levels(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rima Obeid

Prof. (apl.) Dr.

Universität des Saarlandes

Study Sites (1)

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B-Vitamins and Polyneuropathy in Patients... | Clinical Trial