High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study

Aims/hypothesis High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes. Methods Type 2 diabetic patients (21...

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Veröffentlicht in:Diabetologia 2009-02, Vol.52 (2), p.208-212
Hauptverfasser: Rabbani, N, Alam, S. S, Riaz, S, Larkin, J. R, Akhtar, M. W, Shafi, T, Thornalley, P. J
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container_end_page 212
container_issue 2
container_start_page 208
container_title Diabetologia
container_volume 52
creator Rabbani, N
Alam, S. S
Riaz, S
Larkin, J. R
Akhtar, M. W
Shafi, T
Thornalley, P. J
description Aims/hypothesis High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes. Methods Type 2 diabetic patients (21 male, 19 female) with microalbuminuria were recruited at the Diabetes Clinic, Sheikh Zayed Hospital, Lahore, Pakistan, and randomised to placebo and treatment arms. Randomisation was by central office in sequentially numbered opaque, sealed envelopes. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Patients were given 3 x 100 mg capsules of thiamine or placebo per day for 3 months with a 2 month follow-up washout period. The primary endpoint was change in urinary albumin excretion (UAE). Other markers of renal and vascular dysfunction and plasma concentrations of thiamine were determined. Results UAE was decreased in patients receiving thiamine therapy for 3 months with respect to baseline (median -17.7 mg/24 h; p < 0.001, n = 20). There was no significant decrease in UAE in patients receiving placebo after 3 months of therapy (n = 20). UAE was significantly lower in patients who had received thiamine therapy compared with those who had received placebo (30.1 vs 35.5 mg/24 h, p < 0.01) but not at baseline. UAE continued to decrease in the 2 month washout period in both groups, but not significantly. There was no effect of thiamine treatment on glycaemic control, dyslipidaemia or BP. There were no adverse effects of therapy. Conclusions/interpretation In this pilot study, high-dose thiamine therapy produced a regression of UAE in type 2 diabetic patients with microalbuminuria. Thiamine supplements at high dose may provide improved therapy for early-stage diabetic nephropathy. Trial registration: CTRI (India) CTRI/2008/091/000112 Funding: Pakistan Higher Education Commission
doi_str_mv 10.1007/s00125-008-1224-4
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S ; Riaz, S ; Larkin, J. R ; Akhtar, M. W ; Shafi, T ; Thornalley, P. J</creator><creatorcontrib>Rabbani, N ; Alam, S. S ; Riaz, S ; Larkin, J. R ; Akhtar, M. W ; Shafi, T ; Thornalley, P. J</creatorcontrib><description>Aims/hypothesis High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes. Methods Type 2 diabetic patients (21 male, 19 female) with microalbuminuria were recruited at the Diabetes Clinic, Sheikh Zayed Hospital, Lahore, Pakistan, and randomised to placebo and treatment arms. Randomisation was by central office in sequentially numbered opaque, sealed envelopes. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Patients were given 3 x 100 mg capsules of thiamine or placebo per day for 3 months with a 2 month follow-up washout period. The primary endpoint was change in urinary albumin excretion (UAE). Other markers of renal and vascular dysfunction and plasma concentrations of thiamine were determined. Results UAE was decreased in patients receiving thiamine therapy for 3 months with respect to baseline (median -17.7 mg/24 h; p &lt; 0.001, n = 20). There was no significant decrease in UAE in patients receiving placebo after 3 months of therapy (n = 20). UAE was significantly lower in patients who had received thiamine therapy compared with those who had received placebo (30.1 vs 35.5 mg/24 h, p &lt; 0.01) but not at baseline. UAE continued to decrease in the 2 month washout period in both groups, but not significantly. There was no effect of thiamine treatment on glycaemic control, dyslipidaemia or BP. There were no adverse effects of therapy. Conclusions/interpretation In this pilot study, high-dose thiamine therapy produced a regression of UAE in type 2 diabetic patients with microalbuminuria. Thiamine supplements at high dose may provide improved therapy for early-stage diabetic nephropathy. Trial registration: CTRI (India) CTRI/2008/091/000112 Funding: Pakistan Higher Education Commission</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-008-1224-4</identifier><identifier>PMID: 19057893</identifier><language>eng</language><publisher>Berlin/Heidelberg: Berlin/Heidelberg : Springer-Verlag</publisher><subject>Albuminuria - prevention &amp; control ; Associated diseases and complications ; Biological and medical sciences ; Blood Pressure ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - urine ; Diabetes. Impaired glucose tolerance ; Diabetic complications ; Diabetic nephropathy ; Double-Blind Method ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Glomerular Filtration Rate ; Glycated Hemoglobin A - metabolism ; Human Physiology ; Humans ; Internal Medicine ; Kidneys ; Lipids - blood ; Medical sciences ; Medicine ; Medicine &amp; Public Health ; Metabolic Diseases ; Microalbuminuria ; Nephrology. Urinary tract diseases ; noninsulin-dependent diabetes mellitus ; Patients ; Pilot Projects ; Placebos ; Plasma ; Short Communication ; thiamin ; Thiamine - blood ; Thiamine - therapeutic use ; Thiamine - urine ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. 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S</creatorcontrib><creatorcontrib>Riaz, S</creatorcontrib><creatorcontrib>Larkin, J. R</creatorcontrib><creatorcontrib>Akhtar, M. W</creatorcontrib><creatorcontrib>Shafi, T</creatorcontrib><creatorcontrib>Thornalley, P. J</creatorcontrib><title>High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study</title><title>Diabetologia</title><addtitle>Diabetologia</addtitle><addtitle>Diabetologia</addtitle><description>Aims/hypothesis High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes. Methods Type 2 diabetic patients (21 male, 19 female) with microalbuminuria were recruited at the Diabetes Clinic, Sheikh Zayed Hospital, Lahore, Pakistan, and randomised to placebo and treatment arms. Randomisation was by central office in sequentially numbered opaque, sealed envelopes. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Patients were given 3 x 100 mg capsules of thiamine or placebo per day for 3 months with a 2 month follow-up washout period. The primary endpoint was change in urinary albumin excretion (UAE). Other markers of renal and vascular dysfunction and plasma concentrations of thiamine were determined. Results UAE was decreased in patients receiving thiamine therapy for 3 months with respect to baseline (median -17.7 mg/24 h; p &lt; 0.001, n = 20). There was no significant decrease in UAE in patients receiving placebo after 3 months of therapy (n = 20). UAE was significantly lower in patients who had received thiamine therapy compared with those who had received placebo (30.1 vs 35.5 mg/24 h, p &lt; 0.01) but not at baseline. UAE continued to decrease in the 2 month washout period in both groups, but not significantly. There was no effect of thiamine treatment on glycaemic control, dyslipidaemia or BP. There were no adverse effects of therapy. Conclusions/interpretation In this pilot study, high-dose thiamine therapy produced a regression of UAE in type 2 diabetic patients with microalbuminuria. Thiamine supplements at high dose may provide improved therapy for early-stage diabetic nephropathy. Trial registration: CTRI (India) CTRI/2008/091/000112 Funding: Pakistan Higher Education Commission</description><subject>Albuminuria - prevention &amp; control</subject><subject>Associated diseases and complications</subject><subject>Biological and medical sciences</subject><subject>Blood Pressure</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - urine</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Diabetic complications</subject><subject>Diabetic nephropathy</subject><subject>Double-Blind Method</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Glomerular Filtration Rate</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Human Physiology</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Kidneys</subject><subject>Lipids - blood</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Metabolic Diseases</subject><subject>Microalbuminuria</subject><subject>Nephrology. Urinary tract diseases</subject><subject>noninsulin-dependent diabetes mellitus</subject><subject>Patients</subject><subject>Pilot Projects</subject><subject>Placebos</subject><subject>Plasma</subject><subject>Short Communication</subject><subject>thiamin</subject><subject>Thiamine - blood</subject><subject>Thiamine - therapeutic use</subject><subject>Thiamine - urine</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. 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Target tissue resistance</topic><topic>Glomerular Filtration Rate</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Human Physiology</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Kidneys</topic><topic>Lipids - blood</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Metabolic Diseases</topic><topic>Microalbuminuria</topic><topic>Nephrology. Urinary tract diseases</topic><topic>noninsulin-dependent diabetes mellitus</topic><topic>Patients</topic><topic>Pilot Projects</topic><topic>Placebos</topic><topic>Plasma</topic><topic>Short Communication</topic><topic>thiamin</topic><topic>Thiamine - blood</topic><topic>Thiamine - therapeutic use</topic><topic>Thiamine - urine</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. 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S</au><au>Riaz, S</au><au>Larkin, J. R</au><au>Akhtar, M. W</au><au>Shafi, T</au><au>Thornalley, P. J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study</atitle><jtitle>Diabetologia</jtitle><stitle>Diabetologia</stitle><addtitle>Diabetologia</addtitle><date>2009-02-01</date><risdate>2009</risdate><volume>52</volume><issue>2</issue><spage>208</spage><epage>212</epage><pages>208-212</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>Aims/hypothesis High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes. Methods Type 2 diabetic patients (21 male, 19 female) with microalbuminuria were recruited at the Diabetes Clinic, Sheikh Zayed Hospital, Lahore, Pakistan, and randomised to placebo and treatment arms. Randomisation was by central office in sequentially numbered opaque, sealed envelopes. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Patients were given 3 x 100 mg capsules of thiamine or placebo per day for 3 months with a 2 month follow-up washout period. The primary endpoint was change in urinary albumin excretion (UAE). Other markers of renal and vascular dysfunction and plasma concentrations of thiamine were determined. Results UAE was decreased in patients receiving thiamine therapy for 3 months with respect to baseline (median -17.7 mg/24 h; p &lt; 0.001, n = 20). There was no significant decrease in UAE in patients receiving placebo after 3 months of therapy (n = 20). UAE was significantly lower in patients who had received thiamine therapy compared with those who had received placebo (30.1 vs 35.5 mg/24 h, p &lt; 0.01) but not at baseline. UAE continued to decrease in the 2 month washout period in both groups, but not significantly. There was no effect of thiamine treatment on glycaemic control, dyslipidaemia or BP. There were no adverse effects of therapy. Conclusions/interpretation In this pilot study, high-dose thiamine therapy produced a regression of UAE in type 2 diabetic patients with microalbuminuria. Thiamine supplements at high dose may provide improved therapy for early-stage diabetic nephropathy. Trial registration: CTRI (India) CTRI/2008/091/000112 Funding: Pakistan Higher Education Commission</abstract><cop>Berlin/Heidelberg</cop><pub>Berlin/Heidelberg : Springer-Verlag</pub><pmid>19057893</pmid><doi>10.1007/s00125-008-1224-4</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
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subjects Albuminuria - prevention & control
Associated diseases and complications
Biological and medical sciences
Blood Pressure
Diabetes
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - urine
Diabetes. Impaired glucose tolerance
Diabetic complications
Diabetic nephropathy
Double-Blind Method
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Glomerular Filtration Rate
Glycated Hemoglobin A - metabolism
Human Physiology
Humans
Internal Medicine
Kidneys
Lipids - blood
Medical sciences
Medicine
Medicine & Public Health
Metabolic Diseases
Microalbuminuria
Nephrology. Urinary tract diseases
noninsulin-dependent diabetes mellitus
Patients
Pilot Projects
Placebos
Plasma
Short Communication
thiamin
Thiamine - blood
Thiamine - therapeutic use
Thiamine - urine
Urinary system involvement in other diseases. Miscellaneous
Urinary tract. Prostate gland
Vitamin B
title High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study
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