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Recruiting NCT05057806

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Early Phase I Interventional Type2 Diabetes Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 25 MG, Placebo.
Who it may be relevant to
Registry conditions: Type2 Diabetes, Heart Failure With Preserved Ejection Fraction. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Overview

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

Detailed description

The study team will examine effects of elevated plasma ketones caused by 12-week treatment with an SGLT2i (empagliflozin) treatment in participants with T2DM and HF. The study team will focus on three possible mechanisms of action for these effects and test the following:

(i) Skeletal muscle bioenergetics. Using 31P-MRS, the team will quantitate phosphocreatine \[PCr\], ATP, inorganic phosphate, phosphodiester, and intracellular pH. With 1H-MRS, and will measure intramyocellular lipid content at rest and ATPmax production after exercise. The team will examine the relationships between phosphorous metabolite concentrations, intramyocellular lipid content, and ATP generation before and after 12 weeks of SGLT2 inhibition.

(ii) Cardiopulmonary functional capacity.

(iii) Improvements in Patient-Reported Outcomes (PRO). The Patient-Reported Outcomes Measure Information System (PROMIS) Item Bank v2.0 - Physical Function - Short Form 20a will be used to evaluate self-reported physical function and well-being. This tool is a well-developed and validated method to obtain patient self-reported parameters of health in adults.

Interventions

  • Drug Empagliflozin 25 MG
    Empagliflozin 25MG will be administered orally once per day for 3 months
  • Drug Placebo
    The placebo will be administered orally once per day for 3 months

Primary outcome measures

  • Change in Phosphocreatine [Time frame: Baseline to 3 months]
  • Change in Adenosine Triphosphate (ATP) [Time frame: Baseline to 3 months]
  • Change in Inorganic Phosphate [Time frame: Baseline to 3 months]
  • Change in Phosphodiester [Time frame: Baseline to 3 months]
  • ATPmax production [Time frame: Baseline to 3 months]
Secondary outcome measures (5)
  • Plasma Beta-hydroxybutyrate (β-OH-B) [Time frame: Baseline to 3 months]
  • Acetoacetate concentrations [Time frame: Baseline to 3 months]
  • Cardiopulmonary Function [Time frame: Baseline to 3 months]
  • 6 minute walk test [Time frame: Baseline to 3 months]
  • Patient-Reported Outcomes Measure Information System (PROMIS) [Time frame: Baseline to 3 months]

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 23-38 kg/m2
  • Glycated hemoglobin (HbA1c) 5.5-10%
  • Blood Pressure (BP) ≤ 145/85 mmHg
  • Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
  • Stable dose of guideline-directed medications for heart failure and Diabetes
  • Stable body weight (±4 pounds) over the last 3 months
  • Does not suffer from severe claustrophobia
  • No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion criteria

  • Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
  • Pregnancy, lactation or plans to become pregnant
  • Allergy/sensitivity to study drugs or their ingredients
  • Cancer
  • Current drug or alcohol use or dependence
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Texas Health Science Center at San Antonio — San Antonio

Identifiers

NCT: NCT05057806 · HSC20210528H · 2021176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗