Melatonin and Risk Of Cardiovascular Events And Malignant Tumors In The Elderly

Cardiovascular Diseases Clinical Trial

Official title: The Intervention Effect Of Melatonin On The Risk Of Cardiovascular Events And Malignant Tumors In The Elderly: A Prospective, Randomized Parallel Controlled Study Based On Large Cohorts

Status Not yet recruiting

Clinical Trial Summary

Cardiovascular diseases and tumors seriously threaten human health. There are many risk factors that affect the occurrence and death of cardiovascular diseases and malignant tumors. In addition to genetic and congenital factors, it also includes bad lifestyles, such as smoking, drinking, abnormal metabolism, excessive stress, etc. Many factors such as excessive stress and staying up late can cause abnormal circadian rhythms. The regulation of circadian rhythm is likely to be a key key to the early prevention of cardiovascular diseases and tumors.

Melatonin has an important role in regulating the circadian rhythm of the human body. The latest research of our research group confirmed that melatonin can reduce the level of oxidative stress through the retinoic acid-related orphan nuclear receptor alpha (RORα) and thereby inhibit pathological cardiac hypertrophy; melatonin can regulate the polarization and polarization of macrophages RORα receptor stabilizes vulnerable plaque in arteries and prevents plaque rupture.

In China, melatonin is widely used in the market as a health product. However, the protective mechanism of melatonin in cardiovascular diseases and tumors is still unclear, and large-scale population intervention studies are still lacking. The level of melatonin in the daytime changes little with age, but the peak at night gradually decreases with age. In people aged 60 and above, the peak of melatonin at night decreased significantly. We speculate that melatonin supplementation may be able to reduce the oxidative damage of mitochondria by maintaining the level of melatonin at night in the body, delay cell decay, and delay this physiological process.

Therefore, the project team intends to combine the developed new cardiovascular disease and tumor risk prediction models in the Shanghai elderly cohort established in the early stage, and randomize groups of healthy people in the same risk stratification, according to whether or not to supplement melatonin. There are two cohorts: the melatonin intervention cohort and the parallel control cohort. By observing the efficacy indicators of cardiovascular disease and tumor incidence in the two groups during the follow-up period, it provides evidence-based medical evidence for the future clinical application of melatonin.

Clinical Trial Description

Cardiovascular diseases and tumors seriously threaten human health. With the aging of the population in my country, the number of patients with two diseases has been increasing year by year, the difficulty of treatment has greatly increased, and the prognosis of most patients is poor. Therefore, it is of great clinical significance to explore safe and effective intervention programs to prevent cardiovascular diseases and malignant tumors in the elderly.

There are many risk factors that affect the occurrence and death of cardiovascular diseases and malignant tumors. In addition to genetic and congenital factors, it also includes bad lifestyles, such as smoking, drinking, abnormal metabolism, excessive stress, etc. Many factors such as excessive stress and staying up late can cause abnormal circadian rhythms [5, 6]. The regulation of circadian rhythm is likely to be a key key to the early prevention of cardiovascular diseases and tumors.

Melatonin has an important role in regulating the circadian rhythm of the human body. A number of basic and clinical studies at home and abroad have shown that melatonin has a protective effect on inhibiting cardiovascular disease and tumor occurrence. The latest research of our research group confirmed that melatonin can reduce the level of oxidative stress through the retinoic acid-related orphan nuclear receptor alpha (RORα) and thereby inhibit pathological cardiac hypertrophy; melatonin can regulate the polarization and polarization of macrophages RORα receptor stabilizes vulnerable plaque in arteries and prevents plaque rupture.

In China, melatonin is widely used in the market as a health product. Melatonin has a wide range of sources, no obvious toxic and side effects to the body, and high bioavailability, which suggests that it can prevent cardiovascular diseases and It has important potential in the occurrence of tumors. However, the protective mechanism of melatonin in cardiovascular diseases and tumors is still unclear, and large-scale population intervention studies are still lacking. The level of melatonin in the daytime changes little with age, but the peak at night gradually decreases with age. In people aged 60 and above, the peak of melatonin at night decreased significantly. We speculate that melatonin supplementation may be able to reduce the oxidative damage of mitochondria by maintaining the level of melatonin at night in the body, delay cell decay, and delay this physiological process.

Therefore, the project team intends to combine the developed new cardiovascular disease and tumor risk prediction models in the Shanghai elderly cohort established in the early stage, and randomize groups of healthy people in the same risk stratification, according to whether or not to supplement melatonin. There are two cohorts: the melatonin intervention cohort and the parallel control cohort. By observing the efficacy indicators of cardiovascular disease and tumor incidence in the two groups during the follow-up period, it provides evidence-based medical evidence for the future clinical application of melatonin. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Neoplasms

• NCT number: NCT04631341
• Study type: Interventional
• Source: RenJi Hospital
• Contact: Jun Pu, MD,PhD
• Phone: 86-21-68383477
• Email: pujun310@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: December 31, 2026