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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertugliflozin (treated tissue) | Experimental | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin | Drug | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility | The rate of lipolysis was measured under basal, isoproterenol-stimulated, and insulin-suppressed conditions in adipose tissue depots (epicardial, pericardial, and subcutaneous) treated with and without Ertugliflozin. Lipolysis was quantified using a colorimetric assay to determine metabolic flexibility. Cardiac adipose tissue explants cultured with ertugliflozin compared to mock condition. | Time to collect tissue collected during surgery (up to 15 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Secretion Profiles in Adipose Tissue Depots | Levels of cytokines, including MCP1, TNF-β, IL-6, IFN-γ, and IL1-β, were measured in the culture medium of treated and untreated adipose tissue depots (epicardial, pericardial, and subcutaneous) using Luminex assays. Cytokine levels were used to characterize inflammation and response to Ertugliflozin treatment in cardiac adipose tissue explants) and isolated adipocytes after culture with Ertugliflozin vs mock condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Gene Expression Profiles in Adipose Tissue Depots | Expression of genes related to inflammation and lipid metabolism (e.g., MCP1, TNF-β, IL-6) was measured in adipose tissue samples using mRNA extraction and RT-PCR after Ertugliflozin treatment. Analysis was performed to evaluate molecular changes in adipose depots (epicardial, pericardial, and subcutaneous). | Time to collect tissue collected during surgery (up to 15 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracey McLaughlin, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ertugliflozin (Treated Tissue) | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues Ertugliflozin: Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with tissue samples analyzable with optimized assays for lipolysis
| ID | Title | Description |
|---|---|---|
| BG000 | Ertugliflozin (Treated Tissue) | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues Ertugliflozin: Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility | The rate of lipolysis was measured under basal, isoproterenol-stimulated, and insulin-suppressed conditions in adipose tissue depots (epicardial, pericardial, and subcutaneous) treated with and without Ertugliflozin. Lipolysis was quantified using a colorimetric assay to determine metabolic flexibility. Cardiac adipose tissue explants cultured with ertugliflozin compared to mock condition. | Participants with tissue samples analyzable with optimized assays for lipolysis | Posted | Mean | Standard Deviation | µmol/L/hr | Time to collect tissue collected during surgery (up to 15 minutes) | Ertugliflozin-treated tissue samples | Ertugliflozin-treated tissue samples |
|
Average approximately 2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ertugliflozin (Treated Tissue) | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues Ertugliflozin: Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tracey McLaughlin | Stanford University | (650) 725 2430 | tmclaugh@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2024 | Apr 3, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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in vitro experimental study with treated and control tissue samples
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|
|
| Time to collect tissue collected during surgery (up to 15 minutes) |
| Adipose Cell Size Distribution in Pericardial and Subcutaneous Tissue | Adipose cell size distribution was assessed in subcutaneous and pericardial adipose tissue samples using osmium fixation and cell diameter measurements. The relationship between cell size and Ertugliflozin treatment was analyzed. | Time to process tissue samples collected during surgery (up to 15 minutes). |
| Ertugliflozin-treated tissue samples |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| BMI | Mean | Standard Deviation | kg/m² | Participants |
|
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| OG001 | Mock (Control) | Adipose tissue samples collected from participants were incubated without Ertugliflozin to serve as a control condition. |
|
|
| Secondary | Cytokine Secretion Profiles in Adipose Tissue Depots | Levels of cytokines, including MCP1, TNF-β, IL-6, IFN-γ, and IL1-β, were measured in the culture medium of treated and untreated adipose tissue depots (epicardial, pericardial, and subcutaneous) using Luminex assays. Cytokine levels were used to characterize inflammation and response to Ertugliflozin treatment in cardiac adipose tissue explants) and isolated adipocytes after culture with Ertugliflozin vs mock condition. | Participants with tissue samples analyzable with optimized assays for lipolysis | Posted | Mean | Standard Deviation | Mean Fluorescence Intensity (MFI) | Time to collect tissue collected during surgery (up to 15 minutes) | Ertugliflozin-treated tissue samples | Ertugliflozin-treated tissue samples |
|
|
|
| Secondary | Adipose Cell Size Distribution in Pericardial and Subcutaneous Tissue | Adipose cell size distribution was assessed in subcutaneous and pericardial adipose tissue samples using osmium fixation and cell diameter measurements. The relationship between cell size and Ertugliflozin treatment was analyzed. | There were no analyzable aliquots remaining to be allocated to this analysis, all aliquots were allocated for analysis of the primary outcome measures. Additional aliquots cannot be obtained, therefore it is not possible to obtain or report data for this outcome measure. | Posted | Time to process tissue samples collected during surgery (up to 15 minutes). |
|
|
| Other Pre-specified | Gene Expression Profiles in Adipose Tissue Depots | Expression of genes related to inflammation and lipid metabolism (e.g., MCP1, TNF-β, IL-6) was measured in adipose tissue samples using mRNA extraction and RT-PCR after Ertugliflozin treatment. Analysis was performed to evaluate molecular changes in adipose depots (epicardial, pericardial, and subcutaneous). | Not Posted | Time to collect tissue collected during surgery (up to 15 minutes) | Participants |
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
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| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D045505 | Physiological Effects of Drugs |
| TNFB (Explant) |
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| MCP1 (Explant) |
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| IL-6 (Explant) |
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| IFN-G (Adipocytes) |
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| IL1-B (Adipocytes) |
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| TNFB (Adipocytes) |
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| MCP1 (Adipocytes) |
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| IL-6 (Adipocytes) |
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