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Prevention of Renal Complications of Diabetes With Thiamine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Gudrun Caspar-Bell, University of Saskatchewan.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725412
First Posted: November 12, 2012
Last Update Posted: November 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gudrun Caspar-Bell, University of Saskatchewan
  Purpose
Thiamine is a key component in the creation of physiologic anti-inflammatory mediators. Serum thiamine stores have been found to be deficient in diabetic patients. Thiamine deficiency may be a key pathological mechanism of inflammation that results in diabetic kidney and retinal injury. The investigators hypothesize that the repletion of a patient's thiamine by oral supplementation may result in reduced inflammation, and therefore reduced kidney injury.

Condition Intervention Phase
Diabetic Nephropathy Dietary Supplement: Thiamine 300mg PO once daily Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Gudrun Caspar-Bell, University of Saskatchewan:

Primary Outcome Measures:
  • Microabluminuria

Secondary Outcome Measures:
  • Serum Thiamine Level

Other Outcome Measures:
  • Urinary Thiamine Level
  • Inflammatory Markers
    E-selectin, Intercellular Adhesion Molecule 1, von Willebrand Factor, malondialdehyde, glutathione, homocysteine, isoprotein F21, advanced glycation endproducts, receptor for advanced glycation endproducts


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thiamine Supplementation Dietary Supplement: Thiamine 300mg PO once daily
Placebo Comparator: Placebo Dietary Supplement: placebo

Detailed Description:

Thiamine (vitamin B1) is a water-soluble vitamin. It is absorbed from the gastrointestinal tract and taken up into tissues by transport proteins and converted to thiamine pyrophosphate (TPP) by thiamine pyrophosphokinase (TPPK). TPP is a co-factor of pyruvate dehydrogenase (PDH), α-ketoglutarate dehydrogenase and transketolase (TKT)—enzymes involved in the metabolism of glucose.

Various transport proteins are involved in the transport of thiamine monophosphate (TMP) and TPP across membranes. These include thiamine transported isoform-1 (THTR1) and thiamine transporter isoform-2 (THTR2), reduced folate carrier-1 (RFC-1), which transports TMP and TPP across cell plasma membranes and the mitochondrial TPP transporter (mTHTR). Thiamine and TMP/TPP transporters may have abnormal expression in diabetes. Increased THTR1 levels are found in red blood cells (RBCs) and mononuclear leucocytes of patients with diabetes compared to those of healthy subjects. RBC precursors and leucocytes appeared to up-regulate THTR1 expression in response to decreased thiamine availability. In the presence of hyperglycemia, renal tubular epithelial cells, by contrast, have decreased expression. In both experimental models of diabetes and in human diabetics increased clearance of thiamine has been demonstrated. This precedes the development of microalbuminuria. Patients with microalbuminuria and early decline in glomerular filtration rate had higher fractional excretion of thiamine compared to patients with stable renal function.

Thiamine supplementation in STZ- diabetic mice prevented the development of microalbuminuria, decreasing urinary albumin excretion (UAE) by approximately 80%. In addition thiamine supplementation prevented diuresis and glycosuria. Human studies are limited but in one placebo controlled study the thiamine group showed a significant decrease in microalbuminuria in diabetic patients on thiamine.

  Eligibility

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • with a diagnosis of Type II diabetes which has been present for at least 5 years,
  • persistent microalbuminuria (30-299 mg/24 h),
  • HbA1c ≤ 8%, and
  • BMI 19-40 kg/m2.

Exclusion Criteria:

  • significant comorbidities,
  • "deficient renal function" known allergy or intolerance to thiamine,
  • use of thiamine supplements,
  • participation in an interventional study within 30 days,
  • recipients of renal and/or pancreatic transplant and
  • women who were pregnant or breast feeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725412


Contacts
Contact: Gudrun Caspar-Bell, MD 306 966-2044 Gudrun.casparbell@saskatoonhealthregion.ca
Contact: Benjamin M Sehmer, MB 306 261 3932 benjamin.sehmer@usask.ca

Locations
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Contact: Gudrun Caspar-Bell         
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Dr. Gudrun Caspar-Bell, MD University of Saskatchewan
  More Information

Responsible Party: Gudrun Caspar-Bell, Endocrinologist, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01725412     History of Changes
Other Study ID Numbers: Bio REB #12-59
First Submitted: November 8, 2012
First Posted: November 12, 2012
Last Update Posted: November 12, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs