Exogenous Ketone Monoester for Diabetes Mellitus
Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes
See full descriptionAbout the trial for Diabetes Mellitus
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.
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.