Thiamine for Type 2 Diabetes

Overseen By Bhaswati Roy, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Thiamine

Disqualifiers: Stroke, Seizure, Pregnancy, Neuropsychiatric, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it does exclude those currently taking thiamine (vitamin B1). It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Thiamine, Vitamin B1, for Type 2 Diabetes?

Research shows that thiamine (Vitamin B1) supplementation can help improve blood sugar control and reduce cholesterol levels in people with type 2 diabetes. It may also improve glucose tolerance, which is how well the body processes sugar. ^{1 2 3 4 5}

Is thiamine (Vitamin B1) safe for humans?

Thiamine (Vitamin B1) is generally considered safe for humans, and studies have shown that it can be taken in high doses without significant adverse effects. In a study with patients with type 2 diabetes, thiamine supplementation for six months showed improvements in metabolic health without reported safety concerns. ^{2 3 4 6 7}

How does the drug thiamine differ from other treatments for type 2 diabetes?

Thiamine (vitamin B1) is unique because it helps improve glucose metabolism and may reduce complications related to high blood sugar by acting as a coenzyme in important metabolic processes. Unlike standard diabetes medications, thiamine is a vitamin that might address deficiencies linked to diabetes and improve glucose tolerance, potentially offering a novel and inexpensive approach to managing the condition. ^{2 4 6 8 9}

Eligibility Criteria

This trial is for adults with Type 2 Diabetes who may have low levels of thiamine (vitamin B1). Participants will need to visit UCLA twice, three months apart, for about 2.5-3 hours each time. The eligibility criteria are not fully listed here.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

I am not currently admitted to a hospital.

I can lay flat for pictures of my body.

Exclusion Criteria

I have tumors in my brain.

I have a seizure disorder.

I am on dialysis for kidney failure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive thiamine treatment for 3 months to assess improvements in BBB function, cognition, and mood

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Thiamine (Vitamin Supplement)

Trial Overview The study is testing if taking vitamin B1 capsules (thiamine) can improve brain function in people with Type 2 Diabetes. This involves MRI scans, cognitive tests, blood work, and questionnaires over two visits.

Participant Groups

Group I: BBB function, cognition, and mood in T2DM adults with Thiamine treatment. Experimental Treatment 1 Intervention

Analyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group.

Group II: BBB function, cognition, and mood in T2DM adults without Thiamine treatment. Placebo Group 1 Intervention

Analyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group.

Thiamine is already approved in Canada for the following indications:

Approved in Canada as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Thiamine supplementation (100-900 mg/day) for up to 3 months showed no significant improvement in glycaemic outcomes, such as HbA1c, fasting blood glucose, or postprandial blood glucose in patients with type 2 diabetes mellitus, based on a review of six trials involving 364 participants.

However, thiamine supplementation was associated with a significant increase in high-density lipoprotein (HDL) levels and a reduction in triglyceride levels when using benfotiamine at a 120 mg/day dose, suggesting potential cardiovascular benefits despite the lack of impact on blood glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of thiamine supplementation on glycaemic outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. Muley, A., Fernandez, R., Green, H., et al.[2022]

In a pilot study involving 24 drug-naïve patients with type 2 diabetes, thiamine administration (150 mg daily for 1 month) significantly reduced fasting glucose levels from 6.7 to 6.0 mmol/l.

Thiamine also led to a notable decrease in leptin concentrations, from 32.9 to 26.9 ng/ml, indicating potential benefits in metabolic regulation for patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of thiamine administration on metabolic profile, cytokines and inflammatory markers in drug-naïve patients with type 2 diabetes. González-Ortiz, M., Martínez-Abundis, E., Robles-Cervantes, JA., et al.[2021]

In a study of 86 participants, including 60 with type 2 diabetes, thiamine supplementation (100 mg/day for six months) led to significant improvements in cholesterol levels and serum creatinine, indicating potential cardiometabolic benefits.

The results suggest that thiamine supplementation can effectively improve lipid profiles and thiamine levels in patients with type 2 diabetes, making it a promising adjuvant therapy, though further long-term studies are needed to assess its protective effects against diabetes-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Benefits of Six-month Thiamine Supplementation in Patients With and Without Diabetes Mellitus Type 2. Al-Attas, O., Al-Daghri, N., Alokail, M., et al.[2021]

In a study involving 12 hyperglycemic subjects, high-dose thiamine supplementation (300 mg/day) significantly reduced 2-hour plasma glucose levels, indicating improved glucose tolerance compared to baseline.

Thiamine supplementation helped maintain stable fasting plasma glucose and insulin levels, suggesting it may prevent the progression of impaired glucose metabolism towards type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose thiamine supplementation improves glucose tolerance in hyperglycemic individuals: a randomized, double-blind cross-over trial. Alaei Shahmiri, F., Soares, MJ., Zhao, Y., et al.[2022]

After implementing changes to the computerized provider order entry system, the proportion of prescriptions for parenteral thiamine treatment significantly increased from 55.5% to 92.5% in an academic hospital network, indicating improved adherence to treatment guidelines.

The prescribing of higher dosages of parenteral thiamine (≥ 200 mg) also rose dramatically from 1.1% to 61.4%, demonstrating that system changes can effectively enhance the quality of care for patients at risk of thiamine deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving thiamine prescribing at an academic hospital network using the computerized provider order entry system: a cohort study. Day, GS., Ladak, S., Del Campo, CM.[2021]

Individuals with diabetes have significantly lower levels of thiamine and its derivatives compared to those without diabetes, based on a systematic review and meta-analysis of 20 studies involving various thiamine markers.

The findings suggest that people with diabetes may have higher thiamine requirements, especially those with albuminuria, indicating a potential need for thiamine supplementation in this population, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between diabetes and thiamine status - A systematic review and meta-analysis. Ziegler, D., Reiners, K., Strom, A., et al.[2023]

Thiamazole, a medication commonly used to treat hyperthyroidism, may potentially trigger the onset of type 1 diabetes in some individuals.

This finding suggests a need for careful monitoring of blood sugar levels in patients taking thiamazole, as it could have implications for their overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of thiamazole for Graves' disease might trigger the onset of type 1 diabetes. Mizutani, G., Hikima, Y., Satomura, A., et al.[2019]

Thiamine (vitamin B1) is crucial for glucose metabolism and neuronal function, and its deficiency can lead to severe health issues, particularly in diabetic patients who may have increased thiamine needs due to heightened glucose metabolism.

Preliminary evidence suggests that thiamine and its derivative, benfotiamine, may help counteract the harmful effects of high blood sugar on blood vessels, but more clinical trials are needed to confirm their effectiveness in preventing or treating diabetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of thiamine and benfotiamine on intracellular glucose metabolism and relevance in the prevention of diabetic complications. Beltramo, E., Berrone, E., Tarallo, S., et al.[2019]

In a study of 77 type 1 diabetes patients and 81 controls, low blood thiamine levels were strongly associated with increased metabolic syndrome markers, suggesting that thiamine deficiency may worsen diabetes-related complications.

The research indicates that maintaining adequate thiamine levels could help prevent biochemical changes and complications in type 1 diabetes, as thiamine and its phosphate esters were linked to important diabetes biomarkers like HDL, glucose, and triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical changes correlated with blood thiamine and its phosphate esters levels in patients with diabetes type 1 (DMT1). Al-Daghri, NM., Alharbi, M., Wani, K., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of thiamine supplementation on glycaemic outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effect of thiamine administration on metabolic profile, cytokines and inflammatory markers in drug-naïve patients with type 2 diabetes. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Metabolic Benefits of Six-month Thiamine Supplementation in Patients With and Without Diabetes Mellitus Type 2. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

High-dose thiamine supplementation improves glucose tolerance in hyperglycemic individuals: a randomized, double-blind cross-over trial. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Improving thiamine prescribing at an academic hospital network using the computerized provider order entry system: a cohort study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Association between diabetes and thiamine status - A systematic review and meta-analysis. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Administration of thiamazole for Graves' disease might trigger the onset of type 1 diabetes. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Effects of thiamine and benfotiamine on intracellular glucose metabolism and relevance in the prevention of diabetic complications. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Biochemical changes correlated with blood thiamine and its phosphate esters levels in patients with diabetes type 1 (DMT1). [2018]