An observational study in Diabetes Mellitus, Type 2, Vitamin B 12 Deficiency and Vitamin B 6 Deficiency, sponsored by Rima Obeid. Completed. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-14.
Sponsored by Rima Obeid · Observational
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The objective of this study was to evaluate vitamin B deficiency (particularly vitamin B6 deficiency) in diabetic patients in Germany in relation to the presence or absence of proteinuria, and global vascular risk.
This observational study recruited either control subjects or patients with type 2 diabetes for over 5 years and collected information on cardiovascular risk factors. Fasting blood samples and urine were collected and biomarkers of B-vitamins were measured and were related to renal function or to global cardiovascular risk. Global cardiovascular risk was calculated from established models that include Routine clinical and laboratory markers such as plasma lipids, smoking, hypertension, and BMI.
we measured the following markers: Glucose (fasting plasma glucose); HbA1C; serum creatinine; Glomerular filtration rate (GFR), urinary Albumin, C-reactive Protein, Soluble vascular cell adhesion molecule 1 (sVCAM-1), cystatin C, vitamin B1, vitamin B12, holotranscobalamin, methylmalonic acid, homocysteine, and different vitamin B6 forms.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
This study's enrollment of 174 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Rima Obeid as lead sponsor.
Counted across the registry records on this site, refreshed daily.
122 patients with type 2 Diabetes and 52 control subjects were recruited (50% women in both groups).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ambulatory subject >18 years of age
For patients with type 2 Diabetes:
(BMI) 19-40 kg/m2
For healthy controls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apparently healthy subjects without type 2 diabetes
Other: Type 2 diabetes
type 2 Diabetes since 5 years or longer
Other: Type 2 diabetes
Test if patients with diabetes have different blood concentrations of vitamin biomarkers compared with control subjects and if vitamin levels in the patients will differ according to renal damage.
The difference in serum vitamin B12 levels between cases and controls
Compare mean levels of the controls with those in the patients
Time frame: Baseline
The difference in serum vitamin B1 between cases and controls
Compare mean levels of the controls with those in the patients
Time frame: Baseline
The difference in serum vitamin B6 concentrations between cases and controls
Compare mean levels of the controls with those in the patients
Time frame: Baseline
The difference in serum vitamin B12 between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Time frame: Baseline
The difference in serum and urine vitamin B1 between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Time frame: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with and those without albuminuria
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Time frame: Baseline
The difference in serum and urine vitamin B6 vitamers between patients with advanced global vascular risk versus those with a low vascular risk
Compare mean levels of diabetes patients with microalbuminuria and those without microalbuminuria
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No — data will not be shared
Ran from Jan 2011 to primary completion in Sep 2011, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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