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Lay 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).

Category

  • Heart, Vascular and Blood
IRB Number
20180077HU
NCT Number
NCT03560323
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 30 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Type 2 diabetes.
  2. Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %.
  3. Age 30-70 years.
  4. BMI 23-38 kg/m2.
  5. 18 males/18 females.
  6. HbA1c 6.0-9.0 %.
  7. Blood pressure < 145/85 mmHg.
  8. eGFR > 30 mL/min/1.73 m2.
  9. NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).

Exclusion Criteria

  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.

Study Design

Arm Groups

Study Contact

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Ralph DeFronzo