The epidemic of liver disease due to obesity

 Americans are overweight and obese in alarming numbers. This leads to several chronic health problems : Diabetes, High Blood Pressure, Heart Disease and Fatty Liver Disease.

 

Fatty liver occurs when there is accumulation of fat in the liver tissue. This can stay relatively benign but the fat in the liver cells may also give rise to inflammation. Alcohol consumption is a frequent cause but many times it is not due to alcohol. These are Non- Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH), which is the inflammatory form. NASH can lead to scarring of the liver, leading to full-blown cirrhosis and, once cirrhosis has been established, to cancer of the liver (Hepatocellular Carcinoma, HCC).

I have been part of several research studies in this arena and am currently working with Altimmune, a biopharmaceutical company active in this arena.

At this point the best way to get rid of fat in the liver and to reverse to process is to lose weight. This is easier said and done. There are a few, not very effective weight loss medications, and they all should be used as part of a comprehensive weight management program. The most effective way to lose weight and to reverse to process leading to cirrhosis is bariatric surgery.

There are newer medications: the injectables Victosa (Luraglutide) and Rybelsus (Semaglutide). These are more effective and Rybelsus can be administered once weekly. They are GLP-1 agonists. Whena GLP-1 agonist is combined in one molecule with a glucagon receptor agonist, even better results might be achievable with fewer side effects. These promising drug candidates are in clinical trials at this time.

Trends in Clinical Research and Trials

While the world remains impressed by the successful development of COVID-19 vaccines, other aspects of clinical research and trials have also recorded significant progress over the last decade.

The onset of the global health crisis in 2020 set biotech companies worldwide in a race to develop, test, and distribute a vaccine effective against COVID-19 (SARS-CoV-2). The extraordinarily high numbers of ongoing vaccine trials significantly affected enrollment and startup periods. Now that the vaccines have been rolled out, the success of immunization efforts will depend on the vaccines' widespread adoption.

The global pandemic has had a significant impact on clinical trials. Enrollment in trials was suspended initially and later during periods of high COVID-19 contagion risk. With the suspension or pausing of many non-COVID-19 trials, sponsors are already planning subject recruitment for when trials resume once COVID-19 subsides or is brought under control. This will demand editing of research materials and adjustments to patient flow. This must be done in ways that will allow trial sponsors to swiftly get things going when trials restart.

In subject recruitment for clinical trials, an emerging trend is the increased use of digital advertising to target and recruit suitable patients. More than ever before, patients and other potential trial subjects are on their smartphones and other digital devices. It is expected that trial patient recruiters will tap more into new content marketing mediums such as podcast placements in the near future.

The upsurge in remote clinical trials is a new trend. With the remote model gaining more prominence, the traditional supply chain and staff deployment have changed. Clinical trials can now have a larger reach, spanning boundaries including the most distant locations where it was previously impossible to recruit or reach subjects.

The development and wide usage of innovative digital technologies in the 21st century facilitate easier collection and management of clinical trial data. The quicker analysis of data using software platforms is helping sponsors of clinical trials to achieve a more transparent, efficient trial management process.

Internet of Things technology such as connected medical devices is now facilitating physiological data collection from trial subjects. These factors are contributing to greater accuracy, real-time monitoring, and better data sets. The research staff spends less time on data collection and entry, leading to time and resource savings. The need to increase the human connection during clinical trials is growing, and automated follow-up mechanisms such as emails or text messages are gaining prominence.

The world of clinical research is also witnessing an expanding role of independent sites. A critical factor in this regard is their ability to recruits subjects more predictably from their databases or within their medical practices. When compared to large hospitals and academic medical centers, independent sites can also start trials faster. Such sites are smaller and more agile, resulting in increased versatility.

The clinical research area has seen many victories and changes in recent years. Top among these was the development of new medicines to meet new medical challenges such as COVID-19 and unmet demand. The trend is expected to continue through 2021 and beyond.

Colon Cancer & Colon Cancer Screening

The colon is also known as the large intestine. It is the last part of the digestive tract. Colon cancer is also known as colorectal cancer. Although colon cancer can happen at any age, it usually occurs in older adults. The exact cause or causes of colon cancer are not known.

Colon cancer starts with forming non-cancerous or benign clumps of cells in the colon known as polyps. Over time, these polyps can become colon cancer. There may be no symptoms or only a few symptoms when polyps form, making them hard to detect. Regular colon cancer screening is recommended for ages 45 to 75 by the U.S. Preventive Services Task Force.

People who have colon cancer experience no symptoms during the early part of the disease. Later on, the symptoms experienced will depend on both cancer’s size and its location in the large intestine. Symptoms include changes in bowel movement such as diarrhea, constipation, persistent abdominal cramps, and stomach pain. Another symptom is blood in the stool or rectum. People with colon cancer might feel weak or tired all the time. They might also experience unexplained weight loss.

Most people who get colon cancer are over 50, although there is a recent increase in colon cancer for younger people. African-Americans have also been known to have a greater risk for colon cancer. A family history of colon cancer, previous intestinal diseases such as Crohn’s disease, and previous medical conditions involving benign polyps can increase the risk of colon cancer. Other risk factors involved being obese, a low-fiber, high-fat diet, diabetes, and smoking.

The risk factors for colon cancer point to the ideal lifestyle to lower the risk of colon cancer occurrence. This would include exercising daily and maintaining the proper weight. It is recommended to quit smoking and to drink alcohol in moderation. A person should also eat many high-fiber foods such as fruits, vegetables, and whole grains.

Various colon cancer screening tests include stool tests, flexible sigmoidoscopy, colonoscopy, and CT colonography. If the tests such as the stool tests, flexible sigmoidoscopy, and CT colonography results in a positive outcome, meaning that tumors have been detected, a colonoscopy is required to complete the screening.

Stool tests may come in guaiac-based fecal occult blood test (gFOBT), fecal immunochemical test (FIT), and FIT-DNA test. The gFOBT is done once a year and comes in the form of a test kit. This test kit uses chemicals to detect blood in the stool. FIT is also done once a year and uses antibodies to detect blood in the stool. FIT-DNA is done once every three years and detects blood and altered DNA in the stool.

Flexible sigmoidoscopy involves a visual check of the colon and rectum. This is done by inserting a flexible, thin, and lighted tube into the rectum to check for polyps. This type of test is recommended at five-year intervals. Meanwhile, CT colonography uses x-rays of the entire colon to detect abnormalities. This test is also recommended at five-year intervals.

A colonoscopy is a more comprehensive form of flexible sigmoidoscopy. A doctor also uses the thin, lighted tube to inspect the colon and rectum visually. Unlike a flexible sigmoidoscopy, the inspection involves the entire colon, whereas flexible sigmoidoscopy only scans the lower colon. A colonoscopy is recommended at 10-year intervals.