Type2 DiabetesEarly Phase 1NCT05057806
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
A Early Phase 1 study testing Empagliflozin 25 MG in people with Type2 Diabetes and Heart Failure With Preserved Ejection Fraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type2 Diabetes, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 31 Mar 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Carolina Solis-Herrera, MD, 210-567-4800, solisherrera@uthscsa.edu
Francisca M Acosta, PhD, 210-450-8677, acostafm@uthscsa.edu
About this study
Official title: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
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.
Read the 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.
- Being tested
- Empagliflozin 25 MG, Placebo
- Keywords
- Ketones, Cardiovascular benefit
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called Jardiance
Empagliflozin 25MG will be administered orally once per day for 3 months
PlaceboDrug
Also called Placebo for Empagliflozin
The placebo will be administered orally once per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin Group | Experimental | Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months Receives: Drug: Empagliflozin 25 MG |
| Placebo group | Placebo comparator | Subjects will be randomized to receive the empagliflozin placebo for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Phosphocreatine
A measure of phosphocreatine change from baseline to study end
Measured: Baseline to 3 months
Change in Adenosine Triphosphate (ATP)
A measure of ATP change from baseline to study end
Measured: Baseline to 3 months
Change in Inorganic Phosphate
A measure of inorganic phosphate change from baseline to study end
Measured: Baseline to 3 months
Change in Phosphodiester
A measure of phosphodiester change from baseline to study end
Measured: Baseline to 3 months
ATPmax production
Exercise induced ATPmax production change
Measured: Baseline to 3 months
Secondary outcomes (5)
Plasma Beta-hydroxybutyrate (β-OH-B)
Change in β-OH-B
Measured: Baseline to 3 months
Acetoacetate concentrations
Change in acetoacetate concentrations
Measured: Baseline to 3 months
Cardiopulmonary Function
Change in cardiopulmonary functional capacity using oxygen uptake (VO2)
Measured: Baseline to 3 months
6 minute walk test
Change in the distance that can be covered in a 6 minute walk test
Measured: Baseline to 3 months
Patient-Reported Outcomes Measure Information System (PROMIS)
Change in Physical function will be assessed by the PROMIS Item band v2.0 -Physical Function -Short Form 20a to evaluate patient-reported outcomes of physical function and well being.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start13 Jan 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized (2:1) placebo controlled double blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Max and Minnie Tomerlin Voelcker Fund
- Responsible party
- Sponsor
- Investigators
- Carolina Solis-Herrera, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057806
- Sponsor's protocol ID
- HSC20210528H
- Other IDs
- 2021176
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will actively participate in journal clubs and symposia and present abstracts at national meetings, as well as submitting manuscripts to top peer-reviewed journals.