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B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02588898
Enrollment
212
Registered
2015-10-28
Start date
2009-09-30
Completion date
2011-01-31
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications

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.

Interventions

DEVICEBlood 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.

Sponsors

Universität des Saarlandes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Red blood cell cobalamin levelsBaseline
Polyneuropathy grade estimated using a score including a combination of data from questionnaire and electrophysiology investigationsBaselinePolyneuropathy 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

MeasureTime frame
Plasma methylmalonic acid levelsBaseline
Plasma choline levelsBaseline
Plasma cobalamin levelsBaseline

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026