Thiamine for Type 2 Diabetes

Overseen By Bhaswati Roy, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must not be taking: Thiamine

Disqualifiers: Stroke, Seizure, Pregnancy, Neuropsychiatric, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether vitamin B1 (thiamine) can improve brain function, mood, and memory in people with Type 2 Diabetes. Researchers will compare the effects of thiamine capsules to a placebo. Participants must have Type 2 Diabetes, be able to lie flat for imaging, and not currently take thiamine. Those with Type 2 Diabetes who face daily challenges but do not have a history of stroke or certain medical conditions may find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding how thiamine works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that thiamine (vitamin B1) has been studied for safety and effectiveness in people with type 2 diabetes. In one study, patients with early-stage kidney problems related to diabetes experienced a decrease in a marker of kidney stress after taking thiamine for three months, suggesting its safety over that period. Another study examined various health conditions and found that good thiamine levels might reduce the risk of issues like high blood pressure and depression.

Overall, these studies indicate that thiamine is generally safe for people with diabetes, especially since it is a necessary vitamin. However, the current trial is in an early phase, focusing on safety. Ongoing research will provide more information on its safety specifically for improving brain function and mood in type 2 diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 2 Diabetes, which often include medications like metformin or insulin to manage blood sugar levels, thiamine is being investigated for its potential to improve brain health. Thiamine, a vitamin B1, is thought to help improve the function of the blood-brain barrier, cognition, and mood in patients with Type 2 Diabetes. Researchers are excited about thiamine because it offers a novel approach by targeting neurological and cognitive aspects of diabetes, which are not typically addressed by current diabetes medications. This could provide a more holistic treatment option for patients, potentially improving quality of life beyond just blood sugar control.

What evidence suggests that thiamine might be an effective treatment for type 2 diabetes?

This trial will compare the effects of Thiamine treatment with a placebo in adults with type 2 diabetes. Research has shown that thiamine might benefit people with type 2 diabetes. One study found that taking thiamine for a month lowered blood sugar and leptin levels, which are often high in diabetes. Another review found that using thiamine with other supplements also reduced glucose levels. However, not all studies agree; some found no major benefit on blood sugar when taking thiamine alone. There's also a theory that thiamine could improve brain function and mood in people with diabetes, but this is still under investigation. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Thiamine

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

Approved in European Union as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422810/

Effect of thiamine supplementation on glycaemic outcomes in ... Synthesis of results: No significant beneficial effects were observed on glycaemic outcomes with 100–900 mg/day of thiamine or benfotiamine for up to 3 months ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8505293/

Thiamine and diabetes: back to the future? - PMC One-month thiamine administration decreased glycemia and leptin concentrations in subjects with type 2 diabetes [37], and improvements were described in ...

3. mdpi.com mdpi.com/1422-0067/26/9/3932

A Systematic Review of Thiamine Supplementation in ... Personalized supplementation with ALA, carnosine, and thiamine significantly reduced glucose in individuals with type 2 diabetes, potentially through increased ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/doi/10.2337/cd25-0039/163644/Effectiveness-of-Vitamin-B1-6-12-Supplementation

Effectiveness of Vitamin B1-6-12 Supplementation Compared ... Gabapentin showed superior improvement across all measures compared with vitamin B1-6-12 and B12, supporting its role as first-line therapy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06322212

Type 2 Diabetes and Blood Brain Barrier Improvement The investigators hypothesize that thiamine intervention (3-months) will reduce impaired BBB function and will improve cognition and mood functions in T2DM ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0026049523001683

Association between diabetes and thiamine status Compared to controls, individuals with diabetes showed lower concentrations of thiamine (pooled estimate SMD [95 % CI]: −0.97 [−1.89, −0.06]), thiamine ...