CLINICAL TRIAL

Exogenous Ketone Monoester for Diabetes Mellitus

Recruiting · 18+ · All Sexes · Kelowna, Canada

Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes

See full description

About the trial for Diabetes Mellitus

Eligible Conditions
Diabetes Mellitus · Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 2 different treatments. Exogenous Ketone Monoester is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Exogenous Ketone Monoester
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DIETARYSUPPLEMENT

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I was diagnosed with type 2 diabetes by my physician. show original
The author suggests that the person should have stable use of glucose-lowering medications for at least 3 months. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 4 through to Day 10
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 4 through to Day 10.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Exogenous Ketone Monoester will improve 3 primary outcomes, 29 secondary outcomes, and 4 other outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of 2 hours after a meal.

Glucose Control: Continuous Glucose Monitoring
2 HOURS AFTER A MEAL
Post-prandial glucose excursions will be measured by continuous glucose monitoring using the G6 CGM (Dexcom) in both the active and placebo supplement conditions. Post-prandial glucose following breakfast, lunch, and dinner will be averaged together.
Hunger and fullness cravings questionnaire
DAY 0 (PRE-INTERVENTION) THROUGH TO DAY 3
Perceived hunger will be measured on a visual analogue scale questionnaire assessing hunger and fullness. The questions assessed are: How hungry do you feel? (0 = I am not hungry at all; 10 = I have never been more hungry) How satisfied do you feel? (0 = I am completely empty; 10 = I cannot eat another bite) How full do you feel? (0 = Not at all full; 10 = Totally full) How much more do you think you can eat? (0 = Nothing at all; 10 = A lot)
Vascular function
DAY 0 (PRE-INTERVENTION) AND DAY 14 (POST-INTERVENTION)
Vascular function will be assessed by flow mediated dilation of the brachial artery using vascular ultrasound. A cuff will affixed on the forearm, distal to the brachial artery and will be inflated for 5 minutes. Flow mediation dilation will be measured over a 3-minute period following cuff release.
Change from baseline plasma free fatty acids at 14 days
DAY 0 (PRE-INTERVENTION) AND DAY 14 (POST-INTERVENTION)
Free fatty acids from venous blood samples will be measured by colorimetric assay run in duplicate.
T cell Activation
DAY 0 (PRE-INTERVENTION) AND DAY 14 (POST-INTERVENTION)
Markers of T cell activation in whole blood will be quantified by flow cytometry.
Phagocytosis
DAY 0 (PRE-INTERVENTION) AND DAY 14 (POST-INTERVENTION)
Phagocytosis of fluorescent-labelled E. coli by immune cells from whole blood will be quantified by flow cytometry
See More

Who is running the study

Principal Investigator
J. L.
Prof. Jonathan Little, Associate professor
University of British Columbia

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes mellitus, type 2 a year in the United States?

The U.S. Diabetes Organization estimates that 28 million new cases of diabetes and 67 million new cases of Type 2 diabetes have occurred in the United States since 1966.\n

Anonymous Patient Answer

What is diabetes mellitus, type 2?

Diabetes is a common condition. Diabetes mellitus, type 2 has a variety of treatment options. Diabetes affects approximately 125 million individuals worldwide (2012). For the patient and their clinician, diabetes remains extremely frustrating. Diabetes is a debilitating disease with many complications, which includes nephropathy – damage to the kidneys, retinopathy (damage to the retinal nerve fiber layer) (2012). It also affects the cardiovascular system and the brain (2012).

Anonymous Patient Answer

What are common treatments for diabetes mellitus, type 2?

Insulin must be used with dietary restriction to keep blood sugars in check. Other than dietary restrictions, the only other treatment for type 2 diabetes mellitus that is common is physical fitness.

Anonymous Patient Answer

What are the signs of diabetes mellitus, type 2?

Diabetes type 2 can cause a number of signs and symptoms. The combination of these signs can help to provide a more accurate diagnosis of [diabetes type 2](https://www.withpower.com/clinical-trials/diabetes-type-2). Patients may experience: loss of skin wrinkles, dark patches on the skin, a fast or irregular pulse, swelling of the wrists and the big toes. Often, the symptoms develop slowly over several years. The most important sign is low blood sugar in the blood. Diabetes type 2 has many more other features. The signs and symptoms of diabetes type 2 can be as varied as the many forms of diabetes.

Anonymous Patient Answer

What causes diabetes mellitus, type 2?

There is some evidence that the HLA genes may be involved, but this needs to be investigated in a large randomised controlled trial. Genetic markers are still not a promising prospect for predicting type 1 diabetes.

Anonymous Patient Answer

Can diabetes mellitus, type 2 be cured?

In this multicenter study of patients with DM2 we found that more than 95% of patients had a poor glycemic control, and that at least one cardiovascular disease risk factor (dyslipidemia, hypertension, CKD, retinopathy, or angiitis) was found in patients with DM2, who had a similar or better HbA. Findings from a recent study thus support the assumption that DM2 and other autoimmune diseases with an underlying inflammatory/proliferative process are progressive and can not be cured.

Anonymous Patient Answer

How serious can diabetes mellitus, type 2 be?

The majority of patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) mellitus have serious complications and, when complications occur, they often are the result of poor diet and insufficient exercise, not the diabetes. Also, a large proportion of patients with type 2 diabetes mellitus had a history of cardiovascular disease and/or stroke. Because of the increased risk of serious complications, patients with type 2 diabetes mellitus must be monitored and prescribed appropriate medication as needed. Most patients with type 2 diabetes mellitus did not have a history of a microvascular complication; a very small proportion of patients had a history of cardiovascular disease; and a very small proportion of patients had a prior microvascular complication.

Anonymous Patient Answer

Does diabetes mellitus, type 2 run in families?

Results from a recent clinical trial and those from other studies strongly suggest that, in families with diabetes, genes involved in susceptibility to diabetes also affect susceptibility to obesity and type 2 diabetes.

Anonymous Patient Answer

What is exogenous ketone monoester?

EKM can be used in daily clinical practice as a treatment for DKA patients. EKM may be an alternative to TPN for the DKA treatment of critically ill patients; however, its clinical benefits in these groups of patients must be confirmed by larger randomized studies. To do so, more patients with DKA, not only those with DKA plus T2DM, will need to be studied. An alternate method of insulin delivery in a number of DKA patients is to give them insulin in a low-carbohydrate diet, instead of TPN, and to use EKM as the primary insulin. Also, the metabolic effects of EKM are unclear.

Anonymous Patient Answer

What is the average age someone gets diabetes mellitus, type 2?

The mean age of diagnosis of type 2 diabetes in the UK is approximately 8 years later than that reported in the USA. Reasons for this observation include variations in the genetic determinants of type 2 diabetes between the USA and the UK and the differences in the patterns and consequences of diet and lifestyle factors that characterize these countries. This disparity appears to be widening in recent decades. Further investigation of its etiology must include consideration of the increased number of individuals with impaired glucose tolerance.

Anonymous Patient Answer

What does exogenous ketone monoester usually treat?

The use of ME for treatment of diabetic ketosis is becoming increasingly common because ME shows some of the characteristics that patients find most important, like a slow onset and a rapid decline in glycemic levels once ME intake is discontinued.

Anonymous Patient Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

The majority of diabetic patients achieved target HbA1c levels with metformin and in some cases with insulin. Metformin may be more successful at achieving A1c levels <7.0 % than in patients needing insulin due to baseline insulin resistance. The incidence of hypoglycemia was higher with insulin therapy than metformin therapy, suggesting that patients may have more difficulty monitoring their glucose if treatment is based on insulin rather than metformin.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus by sharing your contact details with the study coordinator.