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Thiamine for Diabetic Kidney Disease
Phase 4
Waitlist Available
Led By Dr. Gudrun Caspar-Bell, MD
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Type II diabetes which has been present for at least 5 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether thiamine supplements can help reduce inflammation in people with diabetes, which may in turn help reduce kidney and retinal damage.
Who is the study for?
This trial is for people who have had Type II diabetes for at least 5 years, with a specific kidney condition (microalbuminuria), controlled blood sugar levels (HbA1c ≤ 8%), and a BMI between 19-40. It's not open to those with serious other health issues, thiamine allergies or current use, recent trial participants, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if taking Thiamine (Vitamin B1) daily can prevent kidney damage in diabetics by reducing inflammation. Participants will either receive Thiamine or a placebo without knowing which one they're getting to compare the effects fairly.See study design
What are the potential side effects?
Thiamine is generally considered safe and side effects are rare but may include mild reactions like itching or rash. Since it's a vitamin supplement, severe side effects are not commonly expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type II diabetes for at least 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microabluminuria
Secondary outcome measures
Serum Thiamine Level
Other outcome measures
Inflammatory Markers
Urinary Thiamine Level
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thiamine SupplementationExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,370 Total Patients Enrolled
Dr. Gudrun Caspar-Bell, MDPrincipal InvestigatorUniversity of Saskatchewan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other serious health problems.You are allergic or can't tolerate thiamine.I have received a kidney and/or pancreas transplant.I am currently pregnant or breastfeeding.I have been diagnosed with Type II diabetes for at least 5 years.You have a long-lasting condition where a small amount of protein is found in your urine.I am taking thiamine supplements.Your body mass index (BMI) is between 19 and 40.Your HbA1c level is less than or equal to 8%.
Research Study Groups:
This trial has the following groups:- Group 1: Thiamine Supplementation
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any risk associated with ingesting Thiamine 300mg orally on a daily basis?
"Owing to it being a Phase 4 trial and thus approved, the safety of Thiamine 300mg PO once daily was rated 3 on our scale."
Answered by AI
For whom is this trial an appropriate option?
"This research project is seeking 40 participants with diabetic nephropathy between the ages of 30 and 50. For eligibility, individuals must have a Body Mass Index (BMI) from 19 to 40 kg/m2 as well as a Type II diabetes diagnosis for not less than 5 years."
Answered by AI
Is there an age limit to the participants of this research trial?
"This study requires potential participants to be aged between 30 and 50, adhering strictly to the eligibility criteria."
Answered by AI
Is this trial currently in the process of enrolling participants?
"This evidence-based research is not currently looking for volunteers. It was first posted on the 1st of November 2012 and last updated in late November that same year. However, there are presently 49 other trials actively recruiting participants."
Answered by AI
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