Type 2 Diabetes study: Ketone Monoester
Official title Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
ClinicalTrials.gov ID: NCT06108076
What this study is testing
What is Ketone Monoester (KE)?
This is an investigational oral supplement being studied to see if it changes heart function in people with Type 2 Diabetes and heart failure. It is designed to provide ketones that heart muscle can use for energy without needing insulin.
Also referred to as DeltaG.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if taking oral ketone esters changes how well the heart works in people with type 2 diabetes and heart failure.
- Who it's for
- Adults who have type 2 diabetes and heart failure with reduced ejection fraction.
- What's involved
- Participants will take oral ketone ester capsules and have their heart function measured during the study.
- Phase 1: an early, usually small safety study
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
- people must be on a stable dose of guideline-directed medications for Heart Failure (HF).
- Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
- Age = 18-80 y
- Body Mass Index (BMI) =23-38 kg/m2
- Glycated hemoglobin (HbA1c) = 6.0-10.0%
You likely can't join if
- Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control...
- Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each Magnetic resonance imaging (MRI) study to...
- Allergy/sensitivity to study drugs or their ingredients.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- people with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years)
See the full eligibility criteria
- people must be on a stable dose of guideline-directed medications for Heart Failure (HF).
- Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
- Age = 18-80 y
- Body Mass Index (BMI) =23-38 kg/m2
- Glycated hemoglobin (HbA1c) = 6.0-10.0%
- Blood Pressure (BP) \< 145/85 mmHg
- Estimated Glomerular Filtration Rate (eGFR) \> 30 ml/min 1.73 m2
- For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.
- Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control will be excluded.
- Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each Magnetic resonance imaging (MRI) study to assess current status.
- Allergy/sensitivity to study drugs or their ingredients.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- people with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years)
- Cardiovascular event within the last 3 months
- Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study.
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, 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, but 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?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.