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| Name | Class |
|---|---|
| Kaleida Health | OTHER |
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This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. The primary endpoint of the study is to detect a significant difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will be treated for 12 weeks with placebo once daily |
|
| Dapagliflozin | Active Comparator | 10 mg daily for the 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | SGLT-2 inhibitor for the treatment of type 2 diabetes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use | nuclear factor kappa-light-chain-enhancer of activated B cells measurement through Transcription factor assay | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Expression of Inflammatory Mediators | p47phox in mononuclear cells through real time polymerase chain reaction | 12 Weeks |
| Changes in Expression of Inflammatory Mediators | Suppressor Of Cytokine Signaling 3 measurement in Mononuclear cells through real time polymerase chain reaction |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hypertension Mediators | Plasma concentrations measurement of Angiotensinogen through enzyme-linked immunosorbent assay | 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurement of Angitosensin II through enzyme-linked immunosorbent assay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECMC Ambulatory Center, 3rd Floor | Buffalo | New York | 14215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32044999 | Derived | Ghanim H, Abuaysheh S, Hejna J, Green K, Batra M, Makdissi A, Chaudhuri A, Dandona P. Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgaa057. doi: 10.1210/clinem/dgaa057. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
| FG001 | Dapagliflozin | 10 mg daily for the 12 weeks dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
| BG001 | Dapagliflozin | 10 mg daily for the 12 weeks dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use | nuclear factor kappa-light-chain-enhancer of activated B cells measurement through Transcription factor assay | Out of the 26 total patients in each group, 4 dropped in the placebo arm and 3 dropped in the Dapagliflozin arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
12 weeks
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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 | Placebo | Patients will be treated for 12 weeks with placebo once daily Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paresh Dandona | University at Buffalo | 716-535-1850 | dandona@buffalo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2018 | Oct 24, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Drug |
|
| 12 weeks |
| Changes in Expression of Inflammatory Mediators | Interleukin 1 Beta measurement in mononuclear cells through real time polymerase chain reaction | 12 weeks |
| Changes in Expression of Inflammatory Mediators | c-Jun N-terminal kinase 1 measurement in Mononuclear cells through real time polymerase chain reaction | 12 weeks |
| Changes in Expression of Inflammatory Mediators | Toll-like receptor 4 measurement in mononuclear cells through real time polymerase chain reaction | 12 weeks |
| Changes in Expression of Inflammatory Mediators | Tumor necrosis factor alpha measurement in mononuclear through real time polymerase chain reaction | 12 weeks |
| 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurement of Renin through enzyme-linked immunosorbent assay | 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurement of Atrial natriuretic peptide through enzyme linked immunosorbent assay | 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurement of B-type natriuretic peptide through enzyme linked immunosorbent assay | 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurement of Cyclic guanosine monophosphate through enzyme linked immunosorbent assay | 12 weeks |
| Change in Hypertension Mediators | Plasma concentration measurment of Cyclic adenosine monophosphate through enzyme linked immunosorbent assay | 12 week |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | p47phox in mononuclear cells through real time polymerase chain reaction | Out of the 26 total patients in each group, 4 dropped in the placebo arm and 3 dropped in the Dapagliflozin arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 Weeks |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | Suppressor Of Cytokine Signaling 3 measurement in Mononuclear cells through real time polymerase chain reaction | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | Interleukin 1 Beta measurement in mononuclear cells through real time polymerase chain reaction | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | c-Jun N-terminal kinase 1 measurement in Mononuclear cells through real time polymerase chain reaction | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | Toll-like receptor 4 measurement in mononuclear cells through real time polymerase chain reaction | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
|
|
| Secondary | Changes in Expression of Inflammatory Mediators | Tumor necrosis factor alpha measurement in mononuclear through real time polymerase chain reaction | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | arbitrary unit | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentrations measurement of Angiotensinogen through enzyme-linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | ug/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurement of Angitosensin II through enzyme-linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurement of Renin through enzyme-linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurement of Atrial natriuretic peptide through enzyme linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurement of B-type natriuretic peptide through enzyme linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurement of Cyclic guanosine monophosphate through enzyme linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pmol/mL | 12 weeks |
|
|
|
| Other Pre-specified | Change in Hypertension Mediators | Plasma concentration measurment of Cyclic adenosine monophosphate through enzyme linked immunosorbent assay | Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm | Posted | Mean | Standard Deviation | pmol/mL | 12 week |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Dapagliflozin | 10 mg daily for the 12 weeks dapagliflozin: SGLT-2 inhibitor for the treatment of type 2 diabetes | 0 | 26 | 0 | 26 | 0 | 26 |
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| D004700 | Endocrine System Diseases |