Health TrialsbyHealthPanel

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

ConditionsType2 DiabetesHeart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 25 MG

    Drug

    Empagliflozin 25MG will be administered orally once per day for 3 months

  • Placebo

    Drug

    The placebo will be administered orally once per day for 3 months

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Empagliflozin GroupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Phosphocreatine

A measure of phosphocreatine change from baseline to study end

Time frame
Baseline to 3 months
2

Change in Adenosine Triphosphate (ATP)

A measure of ATP change from baseline to study end

Time frame
Baseline to 3 months
3

Change in Inorganic Phosphate

A measure of inorganic phosphate change from baseline to study end

Time frame
Baseline to 3 months
4

Change in Phosphodiester

A measure of phosphodiester change from baseline to study end

Time frame
Baseline to 3 months

Secondary outcomes

1

Plasma Beta-hydroxybutyrate (β-OH-B)

Change in β-OH-B

Time frame
Baseline to 3 months
2

Acetoacetate concentrations

Change in acetoacetate concentrations

Time frame
Baseline to 3 months
3

Cardiopulmonary Function

Change in cardiopulmonary functional capacity using oxygen uptake (VO2)

Time frame
Baseline to 3 months
4

6 minute walk test

Change in the distance that can be covered in a 6 minute walk test

Time frame
Baseline to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Doris Duke Charitable Foundation

Collaborator

Max and Minnie Tomerlin Voelcker Fund

Collaborator

Source ClinicalTrials.gov
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