Prevention of Renal Complications of Diabetes With Thiamine
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedNovember 12, 2012
November 1, 2012
7 months
November 8, 2012
November 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Microabluminuria
Secondary Outcomes (1)
Serum Thiamine Level
Other Outcomes (2)
Urinary Thiamine Level
Inflammatory Markers
Study Arms (2)
Thiamine Supplementation
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal University Hospital
Saskatoon, Saskatchewan, S7K 0M7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Gudrun Caspar-Bell, MD
University of Saskatchewan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Endocrinologist
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 12, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2013
Last Updated
November 12, 2012
Record last verified: 2012-11