B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Diabetes Complications Clinical Trial

Official title:

B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588898
• Other study ID #: B-vitamins polyneuropathy
• Status: Completed
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Polyneuropathies

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell cobalamin levels		Baseline
Primary	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	Plasma methylmalonic acid levels		Baseline
Secondary	Plasma choline levels		Baseline
Secondary	Plasma cobalamin levels		Baseline