RightFit
RecruitingEarly Phase 1

Ketones, SGLT2, HFrEF

Ketones, Muscle Metabolism, and SGLT2 Inhibitors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Kansas City Cardiomyopathy Questionnaire ( KCCQ) scoring will be used to evaluate self-reported physical function and well-being."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how SGLT2 medicines raise ketones, a fuel the heart can use, in the blood. It will measure changes in how the heart’s main pumping chamber fills and pumps. It is for high-risk adults with type 2 diabetes and heart failure with reduced pumping strength.

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–80 with type 2 diabetes.
  • NYHA class II–III heart failure, with symptoms during physical activity, and ejection fraction below 50% (the share of blood pumped out with each beat).
  • BMI of 23–44 (a measure of weight compared with height), with weight staying within 4 pounds over the past 3 months.
  • HbA1c of 6.0–10.0% (a measure of average blood sugar).
  • Blood pressure of 145/85 or lower.
  • eGFR of at least 30 (a measure of how well the kidneys filter blood).
  • Diabetes treated only with diet and exercise, metformin, sulfonylureas, metformin plus sulfonylureas, GLP-1 receptor agonists, or insulin.
  • Able to understand and follow study steps for the whole study.

Who can't join

  • Heart failure caused by certain problems: stiff heart muscle, active heart muscle swelling, a tight sac around the heart, severe heart valve disease, or thick heart muscle that blocks blood flow.
  • A doubled dose of a diuretic (water pill) or an added heart failure medicine in the month before screening.
  • Taking a DPP-4 inhibitor or pioglitazone for diabetes.
  • Pregnant, breastfeeding, or planning pregnancy. Those who can become pregnant must agree to use birth control if needed and have a negative pregnancy test before each MRI scan.
  • Allergy or sensitivity to the study medicines or their ingredients.
  • Cancer.
  • Drug or alcohol use or dependence that the study doctor believes would prevent following study rules.
  • Unable or unwilling to give written consent to join, either personally or through a legal guardian or representative.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Type 2 Diabetes Mellitus * Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50% * Age 18-80 years * BMI 23-44 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 * Only Type 2 diabetics treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin * Stable body weight (±4 pounds) over the previous 3 months prior to enrollment * Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy. * Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication) * Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone * Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable. * Allergy/sensitivity to study drugs or their ingredients. * Cancer. * 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.

Study sites (1)

TX