Diabetes ComplicationsNCT02588898
B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
An observational study of Diabetes Complications, run by Universität des Saarlandes at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Blood collection and electrophysiological tests
- Type of treatment
- Medical device
- How many people
- 212 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female subjects with or without diabetes.
Who may be able to join
- Male and female subjects with or without diabetes.
Who cannot join
- Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
- Liver or renal dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Blood samples were collected and clinical investigations were performed at the same time.
- Conditions
- Diabetes Complications
- Being tested
- Blood collection and electrophysiological tests
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection and electrophysiological testsDevice
Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blood collection and electrophysiological tests | |
| 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. Receives: Device: Blood collection and electrophysiological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell cobalamin levels
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Plasma methylmalonic acid levels
Measured: Baseline
Plasma choline levels
Measured: Baseline
Plasma cobalamin levels
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Rima Obeid, Dr., Principal investigator, University Hospital of the Saarland, Department of Clinical Chemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588898
- Sponsor's protocol ID
- B-vitamins polyneuropathy
- Status last verified
- May 2018
- First submitted
- 21 Oct 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23168250Obeid 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.
PubMed 26864355
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-Vitamins and Polyneuropathy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02588898
- Acronym / sponsor ID
- B-vitamins polyneuropathy
- Conditions
- Diabetes Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | Device: Blood collection and electrophysiological testsPatients (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 | – | Device: Blood collection and electrophysiological testsControls (both men and women) are people of the same age who are free of Diabetes. Blood collection and electrophysiological tests were performed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects with or without diabetes.
Key inclusion criteria (1 listed)
- Male and female subjects with or without diabetes.
Key exclusion criteria (2 listed)
- Usage of supplements containing B-vitamins, methotrexate treatment, cerebral or cardiac events in the last three months
- Liver or renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection and electrophysiological testsBlood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview. | Device | Controls free of diabetes, Patients with type 2 diabetes |
Primary outcome
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.
3 secondary outcomes
Plasma methylmalonic acid levels
Time frame: Baseline
Plasma choline levels
Time frame: Baseline
Plasma cobalamin levels
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Results publication: PubMed 23168250Obeid 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.
- Derived from this study: PubMed 26864355Obeid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima Obeid, Dr. principal investigator
University Hospital of the Saarland, Department of Clinical Chemistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Complications, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell cobalamin levels (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588898, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.