Dapagliflozin Effects on Epicardial Fat
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/9/2018 |
| Start Date: | September 2015 |
| End Date: | December 2019 |
| Contact: | Gianluca Iacobellis, MD PhD |
| Email: | giacobellis@med.miami.edu |
Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective
sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type
2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a
consistent associated finding. Because dapagliflozin increases urinary glucose excretion,
weight loss could result from reduced body fat secondary to caloric loss or from fluid loss
secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether
Dapaglifozin may cause a reduction in visceral fat is unknown.
Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin
causes a rapid and significant reduction of the epicardial fat, the visceral fat of the
heart, in type 2 diabetic patients.
This hypothesis would be tested in a prospective interventional study in 100 overweight or
obese type 2 diabetes subjects.
sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type
2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a
consistent associated finding. Because dapagliflozin increases urinary glucose excretion,
weight loss could result from reduced body fat secondary to caloric loss or from fluid loss
secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether
Dapaglifozin may cause a reduction in visceral fat is unknown.
Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin
causes a rapid and significant reduction of the epicardial fat, the visceral fat of the
heart, in type 2 diabetic patients.
This hypothesis would be tested in a prospective interventional study in 100 overweight or
obese type 2 diabetes subjects.
Inclusion Criteria:
- • Type 2 diabetes, as defined by ADA criteria
- HbA1c ≤ 8% measured at least 1 week prior to the study
- BMI ≥27 kg/m2
- Pre-treatment with Metformin as monotherapy
- Age > 18 and < 70 years old
Exclusion Criteria:
- • Known contra-indications to Farxiga, in accordance with risks and safety information
included in the latest updated Prescribing Information
- Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- Insulin dependent or treated type 2 diabetes
- Current use of other SGLT2 inhibitors, GLP- 1 analogs or DPP4 inhibitors
- Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
- Patients with poor glycemic control will be excluded to maximize long-term
patient retention without need
- History of diabetes ketoacidosis
- Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV
heart failure
- Clinical or laboratory evidences of chronic active liver diseases
- Acute or chronic infective diseases
- Cancer or chemotherapy
- Current use of systemic corticosteroids or in the 3 months prior this study
- Known or suspected allergy to Dapaglifozin, excipients, or related products
- Pregnant, breast-feeding or the intention of becoming pregnant
- Females of childbearing potential who are not using adequate contraceptive
methods
We found this trial at
2
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Gianluca Iacobellis, MD PhD
University of Miami A private research university with more than 15,000 students from around the...
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University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials