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New treatment option for Type 2 Diabetes
Official title Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
ClinicalTrials.gov ID: NCT06078683
What this study is testing
- What it's testing
- This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 years old and ≤ 80 years old
- Type II Diabetes Mellitus
- Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
- Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
- Body Mass Index (BMI) ≥ 25
You likely can't join if
- Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
- Known allergy or sensitivity to Gadolinium based contrast agents
- Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
- Other metallic implants/aneurysm clips that are contraindicated in MRI
- Claustrophobia
- History of severe kidney disease with eGFR\<30 ml/kg/1.73m2
See the full eligibility criteria
- Age ≥ 18 years old and ≤ 80 years old
- Type II Diabetes Mellitus
- Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
- Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
- Body Mass Index (BMI) ≥ 25
- Ability to participate in exercise treadmill testing (only if CPET is performed)
- Ability to sign written consent
- Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
- Known allergy or sensitivity to Gadolinium based contrast agents
- Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
- Other metallic implants/aneurysm clips that are contraindicated in MRI
- Claustrophobia
- History of severe kidney disease with eGFR\<30 ml/kg/1.73m2
- Type I diabetes
- History of diabetic ketoacidosis
- Prior diagnosis of oxygen dependent pulmonary disease
- Body Mass Index (BMI) \< 25
- Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening
- Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
- Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
- Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or...
- Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator)
- Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study.
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfil the trial requirements or complete the trial
- Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol.
- Unable or unwilling to follow guidelines of assigned supplement group.
- Allergy to test article ingredients, or lactose intolerance
- The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.
- Refusal to consent
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.