Diabetes Clinical Trial

Diabetes Clinical Trial
CBD Clinical Trial

Since the 1980s when the disease was first identified, the numbers of patients who are affected by some form of either diagnosed or undiagnosed diabetes has quadrupled in number to a staggering 422 million people. As of 2016, it has been statistically reported that in the United States alone, every 1 out of 11 people are knowingly or unknowingly affected by diabetes.

For those of you who are new out there, let me give you a quick rundown on what diabetes actually is. So, for starters diabetes is basically more or less of a lifelong condition which up until now, had no potent cure. This primarily occurs due to the body not being able to produce enough insulin or for the fact of the whole mechanism controlling the level of insulin in the body not working properly. As a result, the victim’s blood sugar level rises to a high level, leading to some severe complications if left untreated that include cardiovascular diseases, stroke, retinal damage and kidney failure.

Diabetes has been classified into two types, the first one being Diabetes 1 where the pancreas stops working properly, failing to produce sufficient amounts of insulin. The second one is the type 2 diabetes were the cells stop responding to insulin at a normal level. Type 2 diabetes takes a long time to develop and is the most common form of diabetes to affect people.

Please note that I say “Up until now” because recent studies in the field CBD treatments has led researchers to believe that CBD might actually be able to completely get rid of the problem from its core!

A Little insight into CBD

To fully understand the depths of the clinical Trials, you should know a little bit about CBD in the first place. First and foremost, I would like to eliminate the confusion about Marijuana being a recreational drug. Yes, Marijuana is psychoactive, but there much more to it. Marijuana herbs are comprised of more than 80 different strains from all of those, two strains always steal the limelight, namely CBD and THC. THC is the stain of Marijuana that induces the psychoactive properties, CBD on the other hand is the strain that mostly used for treatment. This strain holds all the health benefits minus the psychoactive properties!

Effects of CBD On Diabetes

Discovered during the 1990s, the endogenous cannabinoid system is the body’s own physiological system responsible for controlling the synthesis and circulation of anything related to Cannabinoid thanks to the presence pharmacologic interactions with the CB1 and CB2 receptors. Several EC agonists include arachidonoylethanolamide and 2-arachidonoylglycerol. These activates the EC system to promote food ingestion, pain reduction and relaxation of muscle.

When working under normal circumstances, the endocannabinoid system works locally and is mostly inactive. But if for some reasons the centrally and peripherally located CB1 receptor comes blocked or remains inactive for a prolonged time, the human body experience a lack of apatite and anorexigenic effects. What ingestion of CBD does here, is that it rapidly helps to activate the endocannabinoid system and excite it, enhancing the stimulation of the CB1 in sensory terminals such as the gastrointestinal tract and liver encouraging increased adiponectin production, inhibition of lipogenesis and of course increased glucose uptake which altogether helps to maintain the body’s homeostasis levels mitigating the amount of excessive glucose in the blood stream, preventing diabetes from kicking in altogether.

Multiple clinical trials has been run on this very subject matter which further tipped forward the case in CBD’s favor.

The Clinical Trials

While carrying on an experiment in animal models obesity, particularly OB Genetic Mouse Models, CBD has shown some very positive metabolic effects leading to decreased chances of Diabetes. During a four weeks’ session using CBD alone (3.0mg/kg), it seemed to produce a 55% increase in plasma HDL cholesterol levels, and reduced total cholesterol levels by more than 25%. In addition, the same dose reduced liver triglyceride and increased liver glycogen levels and increased adiponectin levels. A 1:1 ratio of a combination of THCV and CBD (3.0mg/kg + 3.0mg/kg respectively) also produced positive metabolic effects in the same model: a 50% increase in plasma HDL cholesterol levels, and reduced total cholesterol levels by 19%, reduced liver triglyceride and increased liver glycogen levels, reduced fasting insulin levels and increased energy expenditure at 3 hours post dose.

This researched data suggested that using either of these two cannabinoid, alone or in conjunction with one another, they are able to produce some very desirable effects improving multiple symptoms of diabetes including obesity, insulin sensitivity, hypertension as well as hyperglycemia.

While the former experiment was done using mouse models, the second one was a controlled double blinded “Five Arm” trial consisting of about 62 of Type-2 Diabetes patients, divided into groups of 11 to 14 patients. The whole experiment ran for 13 weeks and was primarily a pilot trial for GWP42004 (5mg), GWP42003 (100mg) and two separate ratios (5mg:5mg and 100mg:5mg) of GWP42003 and GWP42004. Each of the treatment was administered in the form of CBD Oral Capsules given twice daily.

The results of the trial were as follows:

The trial showed that GWP42004, an oral cannabinoid treatment, produced the following desirable anti-diabetic effects: reduced fasting plasma glucose levels (p=0.04), with an increase in fasting insulin, improved pancreatic beta-cell function (p=0.0074), increased serum adiponectin (p=0.0024), reduced systolic blood pressure (p=0.099), and reduced serum IL-6 levels (p=0.076). Other non-significant trends of interest included increased insulin sensitivity, reduced HbA1c, improvement in both glucose & insulin responses to glucose load (OGTT), raised GLP-1 (glucagon-like peptide-1), and reduced serum C-Reactive Protein (CRP) levels. The trial did not show meaningful effects in the other treatment arms.

Clearly it can be seen here, that this was a largely successful trial and created a strong base for the usage of CBD in tackling diabetes and a second phase of this trial was carried out very soon after the completion of this one