TUDCA for High Blood Pressure

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of North Texas Health Science Center

Must not be taking: Beta blockers, Bronchodilators, Anticoagulants, others

Disqualifiers: Tobacco use, Pregnancy, Hyperthyroidism, others

Trial Summary

What is the purpose of this trial?

This trial tests if TUDCA, a substance that reduces cell stress, can lower blood pressure in people with slightly high or stage 1 high blood pressure. By reducing cell stress, TUDCA may help lower harmful substances that raise blood pressure and damage blood vessels.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that alter vascular function, beta blockers, bronchodilators, anti-coagulants, hormone replacement therapy, and PDE3 inhibitors. If you are on any of these, you may need to stop them before participating, but it's best to discuss with the study team for specific guidance.

How does the drug TUDCA differ from other treatments for high blood pressure?

TUDCA is unique because it is a naturally occurring bile acid traditionally used in Chinese medicine, and it has shown potential in treating various conditions due to its multiple effects, including neuroprotection and renoprotection. Unlike standard high blood pressure treatments, TUDCA's novel mechanism involves reducing stress in cells, which may offer additional benefits beyond blood pressure control. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adults aged 18-80 with high blood pressure who are non-smokers, not pregnant, and have a BMI under 35. They must have normal heart health as shown by an ECG and cannot be on certain medications like beta blockers or blood thinners. People with serious health issues such as uncontrolled heart rhythm problems, recent concussions, drug abuse history, cancer, severe allergies including latex or needle phobia are excluded.

Inclusion Criteria

I am a woman and have a negative pregnancy test or am post-menopausal.

Your blood pressure is below 140/90 mmHg.

Normal clinical results from a medical exam reviewed by a board-certified physician (e.g., General Health Questionnaire obtained at the Screening and Familiarization Visit)

Exclusion Criteria

I weigh less than 80 lbs.

I am currently taking beta blockers.

I use bronchodilators every day.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tauroursodeoxycholic acid or placebo to inhibit endoplasmic reticulum stress

4-8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Placebo (Other)
• TUDCA (Other)

Trial Overview The study tests TUDCA (a compound thought to reduce stress in cells) against a placebo to see if it can help manage hypertension in humans. Participants won't know which they're receiving in this single-blind setup where the researchers but not the subjects know what treatment is being given.

Participant Groups

Group I: Endoplasmic Reticulum Stress Inhibition Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of North Texas Health Science Center

Lead Sponsor

Trials

41

Recruited

20,800+

Findings from Research

In a study of 199 Chinese patients with primary biliary cholangitis (PBC), tauroursodeoxycholic acid (TUDCA) demonstrated similar efficacy to ursodeoxycholic acid (UDCA) in reducing serum alkaline phosphatase (ALP) levels after 24 weeks of treatment.

TUDCA was found to be safer, as it did not increase the incidence of pruritus (itching), which rose significantly in the UDCA group, indicating that TUDCA may provide symptom relief without the side effects associated with UDCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis. Ma, H., Zeng, M., Han, Y., et al.[2023]

In a study of 258 ALS patients, those treated with oral tauroursodeoxycholic acid (TUDCA) showed a median overall survival of 49.6 months, compared to 36.2 months for those receiving standard care, suggesting a potential survival benefit from TUDCA treatment.

Higher dosages of TUDCA (≥1000 mg/day) were associated with a significantly reduced risk of death (HR 0.56), and the treatment was generally well-tolerated, with only a small percentage of patients experiencing mild gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tauroursodeoxycholic acid on survival and safety in amyotrophic lateral sclerosis: a retrospective population-based cohort study. Zucchi, E., Musazzi, UM., Fedele, G., et al.[2023]

Tauroursodeoxycholic acid (TUDCA) has shown significant neuroprotective effects in various retinal disorders, including retinitis pigmentosa and diabetic retinopathy, based on a systematic review of 24 studies involving both in vitro and in vivo experiments.

The mechanisms by which TUDCA exerts its protective effects include inhibiting apoptosis, reducing inflammation, alleviating oxidative stress, and suppressing endoplasmic reticulum stress, suggesting it could be a promising therapeutic agent for retinal diseases, although further clinical trials are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Tauroursodeoxycholic Acid (TUDCA) on In Vitro and In Vivo Models of Retinal Disorders: A Systematic Review. Li, J., Huang, Z., Jin, Y., et al.[2023]

Tauroursodeoxycholic acid (TUDCA) shows promise as a treatment for diabetic kidney disease (DKD), particularly when used in combination with telmisartan, an established angiotensin II receptor blocker, based on both in vitro and in vivo studies involving Wistar rats.

The combination therapy of TUDCA and telmisartan was more effective in improving renal function and reducing cell death and fibrosis compared to either treatment alone, suggesting that TUDCA could be a valuable addition to current DKD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the potential of tauroursodeoxycholic acid as add-on therapy in amelioration of streptozotocin-induced diabetic kidney disease. Sankrityayan, H., Shelke, V., Kale, A., et al.[2023]

In a double-blind randomized trial involving 23 patients with liver cirrhosis, tauroursodeoxycholic acid (TUDCA) showed a significant reduction in serum ALT, AST, and ALP levels compared to baseline, indicating its potential therapeutic efficacy over 6 months.

Both TUDCA and ursodeoxycholic acid (UDCA) were well tolerated with no reported side effects, but TUDCA appeared to be more effective in improving biochemical markers of liver function, although neither treatment significantly affected liver fibrosis markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: a double-blind randomized controlled trial. Pan, XL., Zhao, L., Li, L., et al.[2021]

References

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

A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effect of tauroursodeoxycholic acid on survival and safety in amyotrophic lateral sclerosis: a retrospective population-based cohort study. [2023]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Tauroursodeoxycholic Acid (TUDCA) on In Vitro and In Vivo Models of Retinal Disorders: A Systematic Review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the potential of tauroursodeoxycholic acid as add-on therapy in amelioration of streptozotocin-induced diabetic kidney disease. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: a double-blind randomized controlled trial. [2021]