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Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT04882332
Recruitment Status : Not yet recruiting
First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Mona Youssry Helmy, Cairo University

Tracking Information
First Submitted Date April 28, 2021
First Posted Date May 11, 2021
Last Update Posted Date May 11, 2021
Estimated Study Start Date May 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2021)
Correlation between Metformin Usage Index and Vitamin B12 status among Egyptian patients with type 2 diabetes [ Time Frame: 6 months ]
The relationship between MUI and vitamin B12 levels will be assessed among the studied groups
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients
Official Title Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients : A Case Control Study .
Brief Summary

Current data estimated that 451 million people, (age 18-99 years) suffered from diabetes world wide in 2017, and are expected to rise to 693 million by 2045. Among them, type 2 diabetes mellitus (T2DM) accounts for around 90% of all cases with diabetes.

T2DM is associated with several deterimental microvascular and macrovascular complications (Annani-Akollor ME et al ., 2019) . As such, effective management of the disease is crucial.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommend metformin as the first therapeutic choice for T2DM management with concurrent lifestyle modifications. Reports indicated that metformin improves peripheral insulin sensitivity and reduces the risk of cardiovascular mortality in T2DM in addition to its beneficial effects on weight loss and vascular protection.

Nonetheless, as with most medications, metformin has some side effects. Though most of these side effects are mild, reports indicated that metformin use is associated with diminution of vitamin B12 level . Also, advanced age of patients with T2DM, nutritional deficiency, and malabsorption are other contributing factors for its deficiency .

The proposed mechanisms for deficiency include, impairment of calcium dependent absorption from the gut, alteration in small bowel motility resulting in bacterial overgrowth, and a reduction in intrinsic factor levels .

Metformin-induced vitamin B12 deficiency has also been associated with neuropathy. The neuropathy associated with vitamin B12 deficiency ranges from paresthesia and attenuated peripheral sensation in response to changes in mental status and proprioception which overlap with diabetic neuropathy.

The progression of vitamin B12 deficiency-induced neurologic damage can, however, be abated through early detection and vitamin B12 therapy. Nonetheless, if peripheral neuropathy due to deficiency of vitamin B12 is misconstrued as diabetic peripheral neuropathy , permanent neurological damage may occur.

Several studies have investigated the individual effects of the dose and duration of metformin therapy on vitamin B12 levels .The reported results are inconsistent, with some studies reporting an association with the dose but not the duration and other studies reporting an association only for the duration. however, A few studies did not find an association with either the dose or the duration..

This could be attributed to the fact that, in any given patient with T2DM, vitamin B12 levels could be influenced predominantly by either the dose or the duration of metformin therapy. Hence, it is important to involve both the dose and duration of metformin therapy into the assessment of vitamin B12 deficiency.

Micronutrient deficiencies constitute a global health issue, particularly among countries in the Middle East .The World Health Organization (WHO) has divided this region into overlapping country clusters with regard to nutrition stages and dominant nutrition problems, including major risk factors and underlying causes, program interventions, and gaps in response to these problems.

Countries in early nutrition transition (e.g., Egypt, Jordan, Lebanon, Morocco, and Palestine) are typically characterized by a moderate prevalence of overweight and obesity, moderate levels of undernutrition in specific population groups, and widespread micronutrient deficiencies/inadequacies.

Metformin Usage Index is the product of the dose of metformin (mg) used and its duration divided by 1000. An index which incorporates both of these factors would not only be useful to understand the cumulative impact on vitamin B12 levels but also provide an objective threshold for initiating vitamin B12 supplementation .

So , we aimed to assess the relationship between the dose and duration of metformin therapy with vitamin B12 levels using the "Metformin Usage Index" (MUI) in Egyptian type 2 diabetic patients where the incidence of nutritional deficiencies are not uncommom in order to formulate their appropriate management strategies .

The aim of our study is to evaluate the combined effect of both dose and duration of metformin therapy on vitamin B12 levels in Egyptian patients with type 2 diabetes mellitus (T2D).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 108 patients aged 20 to 65 years old with controlled and uncontrolled type 2 DM
Condition Diabetes Mellitus
Intervention
  • Other: sampling for diabetes control parameters
    Intravenous blood withdrawal for a sample of fasting blood glucose (FBG), 2 hr postprandial blood glucose (2 hr -PPG), fasting lipids {total cholesterol (TC), triglycerides (TAG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)}, glycosylated hemoglobin (Hb A1c) ,fasting insulin level and Vitamin B 12 levels
  • Other: Sampling for vitamin B12 level
    Intravenous blood sampling for a sample of vitamin B12 level
Study Groups/Cohorts metformin usage index and vitamin B12 level
Samples for correlation between metformin usage index and vitamin B1 level will be withdrawn from 108 type 2 diabetes patients
Interventions:
  • Other: sampling for diabetes control parameters
  • Other: Sampling for vitamin B12 level
Publications * Ahmed MA, Muntingh G, Rheeder P (2016) Vitamin B12 deficiency in metformin-treated type-2 diabetes patients, prevalence and association with peripheral neuropathy. BMC Pharmacol Toxicol 17(1):44. https ://doi.org/10.1186/s4036 0-016-0088-3. Alvarez M, Sierra OR, Saavedra G, Moreno S (2019) Vitamin B12 deficiency and diabetic neuropathy in patients taking metformin: a cross-sectional study. Endocr Connect 8(10):1324- 1329. https ://doi.org/10.1530/EC-19-0382. Annani-Akollor ME, Addai-Mensah O, Fondjo LA, et al.(2019) Predominant complications of type 2 diabetes in kumasi: a 4-year retrospective cross-sectional study at a teaching hospital in Ghana. Medicina (B Aires). 2019;55(5): 125.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 8, 2021)
108
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women aged 20 to 65 years old with controlled and uncontrolled type 2 DM

Exclusion Criteria:

  • T2DM patients who are pregnant/lactating women,
  • newly diagnosed with T2DM (< 3 months),
  • who receive vitamin B12 supplementation or proton-pump inhibitors over the last 6 months,
  • alcoholics ,
  • known cases of malabsorption (gastrointestinal surgery, inflammatory bowel diseases and gluten allergy),
  • chronic kidney disease,
  • pernicious anemia
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nehal H Elsaid 01004389020 ext 02 nihalhamdyelsaid@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04882332
Other Study ID Numbers N-25-2021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: not to share
Responsible Party Mona Youssry Helmy, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date May 2021