Pendulum's published clinical study explained

Our published clinical study, explained

This guest post is written by Hope Warshaw, MMSc, RD, CDCES, BC-ADM.
Hope is a Registered Dietitian (RD) and Certified Diabetes Care and Education Specialist (CDCES) who has been involved in diabetes care, education and support for over 40 years.
She has and continues to apply her credentials as a consultant, book author, freelance writer and media spokesperson within her business, Hope Warshaw Associates, LLC, a consultancy based in Asheville North Carolina. Hope serves as a consultant to Pendulum Therapeutics.

More often than not, the organ people typically associate diabetes with is the pancreas.

That’s because the management of diabetes has historically focused on insulin, which is the hormone produced and secreted from the pancreas.

Suffice to say, our collective understanding of how people develop r Type 2 or Type 1 diabetes has greatly evolved, and they’re actually quite different.

This blog post will focus on Type 2 diabetes. It will zero in on positive outcomes from a study in people with Type 2 diabetes, which studied the use of Pendulum Glucose Control for the management of A1C and after-meal blood-glucose spikes.

Overall, the study showed a significant improvement in both short- and longer-term measures of blood-glucose control after eating.[1] 

Let’s explore the details.    

Study background 

This study was conducted due to a growing body of research that has shown several changes that occur in the gut microbiome of people with Type 2 diabetes.

This includes lower-than-usual amounts of certain naturally occurring gut bacteria—specifically the healthy microbe Akkermansia muciniphilaand other microbes that convert dietary fiber into short-chain fatty acids—particularly butyrate.

Butyrate supports digestive health. Research shows that a stable gut barrier and sufficient butyrate production are important to maintaining a healthy gut and normal glucose levels.      

Study purpose

The hypothesis of this study was that people diagnosed with Type 2 diabetes who regularly took a novel, butyrate- and Akkermansia muciniphila-producing synbiotic (probiotic & prebiotic) would experience improved blood-glucose control. 

The product tested in this study was Pendulum Glucose Control.  

Study design

The study tested two formulations of the synbiotic both taken two times a day.

The study lasted 12 weeks.

It was a randomized, parallel (meaning the study was conducted at the same time), double-blind (meaning neither the participants nor the researchers knew who were in each study group), and placebo-controlled (meaning people were randomly assigned to either receive one of the synbiotics or placebo) study. 

Study participants

A total of 76 people with Type 2 diabetes located in six study sites were included in this study.

Their Type 2 diabetes was being managed with healthy eating and physical activity alone, combined with the glucose-lowering medication metformin, or—in some cases—one other category of medication called sulfonylureas.

Most participants were overweight or obese, had A1C levels ranging from 8.5 – 8.9%, and fasting blood-glucose levels ranging from 179 – 208 mg/dL. 

Interestingly, it has been conjectured that metformin, which is a widely used initial medication to manage Type 2 diabetes, may assist in improving gut health by increasing butyrate and Akkermansia muciniphila.[1] 

Study results

Study participants who received Pendulum Glucose Control in comparison to the placebo group showed clinically significant improvements in blood-glucose levels, which were measured in two ways:

1) By a meal-tolerance test, which shows the rise of blood glucose over three hours after consuming a standardized liquid beverage (results reported as glucose area under the curve), and

2) By an A1C test.

The glucose area under the curve improved by 36 mg/dL over 180 minutes, and the A1C improved by 0.6% compared to the placebo results.

It is important to note that there were no safety concerns or issues tolerating the synbiotic during the study.     

What do these results mean for people with type 2 diabetes?
  • Type 2 diabetes is a progressive disease.
  • Over a number of years—typically in the range of 10 to 15 years—a person’s ability to continue to make a sufficient supply of insulin to keep their glucose levels under control can dwindle.
  • The earlier you take action in the course of your Type 2 diabetes diagnosis (which includes eating sufficient fiber every day) the earlier you can keep your blood-glucose levels under control to slow this progression.  
  • As this study shows, these negative changes may be positively impacted with the use of Pendulum Glucose Control.   
  •  

    What is glucose management?

    It’s easy to be confused by the numbers that the American Diabetes Association recommends for the diagnosis of Type 2 diabetes and the blood-glucose and A1C management targets.[2]

    Once you’ve been diagnosed with Type 2 diabetes you want to know and try to reach the management targets. (Diagnostic targets are different.) 

    Discuss with your healthcare provider how often you should have your A1C checked.

    Also, discuss how (whether with a Blood Glucose Meter or personal Continuous Glucose Monitor) and how often to check your blood-glucose levels. 

    Key ways to measure your glucose levels:

    • A1C: The goal for many non-pregnant adults is <7%, but you and your provider may decide that a less-stringent goal of <8%, is appropriate for you bearing in mind your personal medical situation and other factors.[3] A1C is reported as a percent and is one number. It gives a sense of all the ups and downs of your glucose levels over the last two to three months. It doesn’t give you specifics about the ups and downs of your glucose levels like checking your glucose levels does. 
    • Glucose levels:
      • Before meals and fasting: 80 – 130 mg/dL
      • After eating (1-2 hours after the beginning of meals): <180 mg/dL 

     

    References: 

    1. Perraudeau F, McMurdie P, Bullard J, et al. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Research and Care. 2020;8:e001319. doi: 10.1136/bmjdrc-2020-001319.
    2. American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes - 2020. Diabetes Care. 2020;43(suppl 1):S66-S76.

       

       

      Before you consider any of these gut-microbiome dietary solutions, talk to your healthcare provider. 
      The FDA has not approved or evaluated these statements. Pendulum products are not intended to diagnose, treat, cure, or prevent any diseases. Results may vary.

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