Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

Description

To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).

Conditions

Heart Failure, Type 2 Diabetes Mellitus

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Study Details

Study overview

To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1.

Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

San Antonio

Texas Diabetes Institute - University Health System, San Antonio, Texas, United States, 78207

San Antonio

University of Texas Health Science Center San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Type 2 diabetes.
  • 2. Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %.
  • 3. Age 18-80 years.
  • 4. BMI 23-38 kg/m2.
  • 5. HbA1c 6.0-9.0 %.
  • 6. Blood pressure \< 145/85 mmHg.
  • 7. eGFR \> 30 mL/min/1.73 m2.
  • 8. NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).
  • 1. Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin.
  • 2. Women who are pregnant or breastfeeding.
  • 3. Contraindications for MRI include metal plates, parts, screws, shrapnel, pins in the body, or cardiac pacemaker.
  • 4. Any other condition that in the opinion of the investigator create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Ralph A DeFronzo, MD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio

Study Record Dates

2027-02