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| ID | Type | Description | Link |
|---|---|---|---|
| 2021176 | Other Grant/Funding Number | Doris Duke Charitable Foundation |
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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
| Max and Minnie Tomerlin Voelcker Fund | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin Group | Experimental | Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months |
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| Placebo group | Placebo Comparator | Subjects will be randomized to receive the empagliflozin placebo for 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | Empagliflozin 25MG will be administered orally once per day for 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Phosphocreatine | A measure of phosphocreatine change from baseline to study end | Baseline to 3 months |
| Change in Adenosine Triphosphate (ATP) | A measure of ATP change from baseline to study end | Baseline to 3 months |
| Change in Inorganic Phosphate | A measure of inorganic phosphate change from baseline to study end | Baseline to 3 months |
| Change in Phosphodiester | A measure of phosphodiester change from baseline to study end | Baseline to 3 months |
| ATPmax production | Exercise induced ATPmax production change | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Beta-hydroxybutyrate (β-OH-B) | Change in β-OH-B | Baseline to 3 months |
| Acetoacetate concentrations | Change in acetoacetate concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Solis-Herrera, MD | Contact | 210-567-4900 | solisherrera@uthscsa.edu | |
| Francisca M Acosta, PhD | Contact | 210-450-8677 | acostafm@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolina Solis-Herrera, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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.
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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A randomized (2:1) placebo controlled double blind study
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Participants and investigators will be blinded to the randomization.
| Placebo | Drug | The placebo will be administered orally once per day for 3 months |
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| Baseline to 3 months |
| Cardiopulmonary Function | Change in cardiopulmonary functional capacity using oxygen uptake (VO2) | Baseline to 3 months |
| 6 minute walk test | Change in the distance that can be covered in a 6 minute walk test | 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. | Baseline to 3 months |