Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial

•Add-on vitamin B12 improved glycaemic control in patients with type 2 diabetes.•Median HbA1c change was – 1.2 % with vitamin B12 versus 0.3 % with control (p = 0.04).•Vitamin B12 also markedly improved insulin resistance & serum adiponectin (p 

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Veröffentlicht in:Complementary therapies in medicine 2020-09, Vol.53, p.102526-102526, Article 102526
Hauptverfasser: Satapathy, Swayamjeet, Bandyopadhyay, Debapriya, Patro, Binod Kumar, Khan, Shahnawaz, Naik, Sanjukta
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container_title Complementary therapies in medicine
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creator Satapathy, Swayamjeet
Bandyopadhyay, Debapriya
Patro, Binod Kumar
Khan, Shahnawaz
Naik, Sanjukta
description •Add-on vitamin B12 improved glycaemic control in patients with type 2 diabetes.•Median HbA1c change was – 1.2 % with vitamin B12 versus 0.3 % with control (p = 0.04).•Vitamin B12 also markedly improved insulin resistance & serum adiponectin (p 
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This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus. This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups – Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks. HbA1c improved significantly in Groups B and C [median changes from baseline – 1.2 % (– 13 mmol/mol) and – 1.5 % (– 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups. Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.</description><identifier>ISSN: 0965-2299</identifier><identifier>EISSN: 1873-6963</identifier><identifier>DOI: 10.1016/j.ctim.2020.102526</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adiponectin ; Antidiabetics ; Biochemistry ; Blood pressure ; Clinical trials ; Cyanocobalamin ; Data collection ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetic neuropathy ; Dietary supplements ; Fasting ; Folic acid ; Glucose ; Homocysteine ; Insulin ; Insulin resistance ; Kinases ; Lipids ; Metabolism ; Patients ; Plasma ; Tumor necrosis factor-TNF ; Type 2 diabetes mellitus ; Vitamin B ; Vitamin B 12 ; Vitamin B12</subject><ispartof>Complementary therapies in medicine, 2020-09, Vol.53, p.102526-102526, Article 102526</ispartof><rights>2020 Elsevier Ltd</rights><rights>2020. 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This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus. This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups – Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks. HbA1c improved significantly in Groups B and C [median changes from baseline – 1.2 % (– 13 mmol/mol) and – 1.5 % (– 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups. 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serum adiponectin (p &lt; 0.05).•High degree of safety noted for add-on vitamin B12 with no observed adverse effect. This study was conducted to investigate and compare the effects of add-on folic acid and vitamin B12 supplementation on glycaemic control, insulin resistance and serum lipid profile in subjects with type 2 diabetes mellitus. This study was a randomized, multi-arm, open-label clinical trial. 80 patients with type 2 diabetes and on stable oral antidiabetics were enrolled and 20 patients each were randomly allocated to one of the four groups – Group A: add-on Folic acid (5 mg/day); Group B: add-on Methylcobalamin (500 mcg/day); Group C: add-on Folic acid (5 mg/day) + Methylcobalamin (500 mcg/day) and Group D: Standard oral anti-diabetic drugs. The patients were followed up after 8 weeks. HbA1c improved significantly in Groups B and C [median changes from baseline – 1.2 % (– 13 mmol/mol) and – 1.5 % (– 16 mmol/mol) respectively, p values 0.04 and 0.02 respectively] compared to Group D. Groups B and C also showed significant improvements in plasma insulin, insulin resistance and serum adiponectin compared to Group D. Serum homocysteine declined significantly in all three groups with add-on supplementation compared to standard treatment. No improvement in the lipid profile was noted in any of the groups. Add-on supplementation with vitamin B12 improved glycaemic control and insulin resistance in patients with type 2 diabetes mellitus.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><doi>10.1016/j.ctim.2020.102526</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record>
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subjects Adiponectin
Antidiabetics
Biochemistry
Blood pressure
Clinical trials
Cyanocobalamin
Data collection
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetic neuropathy
Dietary supplements
Fasting
Folic acid
Glucose
Homocysteine
Insulin
Insulin resistance
Kinases
Lipids
Metabolism
Patients
Plasma
Tumor necrosis factor-TNF
Type 2 diabetes mellitus
Vitamin B
Vitamin B 12
Vitamin B12
title Folic acid and vitamin B12 supplementation in subjects with type 2 diabetes mellitus: A multi-arm randomized controlled clinical trial
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