Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04882332
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2021-04-28
Brief Title:
Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients A Case Control Study
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 deficienciesinadequacies
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 the aim of this study is 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
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 eg 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 deficienciesinadequacies
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 the aim of this study is 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None