Dapagliflozin Effects on Epicardial Fat

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.

Official Title
-----------------
Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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 < 65 years old Normal and stable hemodynamic status 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, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2 Signs or symptoms of hypovolemia Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need History of diabetes ketoacidosis Patients with active bladder cancer or with a prior history of bladder cancer Acute or chronic infective, including genital mycotic infections 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 Dapagliflozin, excipients, or related products Pregnant, breast-feeding or the intention of becoming pregnant Females of childbearing potential who are not using adequate contraceptive methods

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin and Metformin Group<br>Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. | Drug: Dapagliflozin<br>* 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.<br>* Other names: Farxiga;Drug: Metformin<br>* 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL<br>|
| Active Comparator: Metformin and Placebo Group<br>Participants in this group will receive Metformin and Placebo for 6 months. | Drug: Metformin<br>* 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL<br>Drug: Placebo<br>* Placebo pill taken once daily to mimic Dapagliflozin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicardial Fat Thickness | Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks | At Baseline, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Mass (LVM) | LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24 | At Baseline, Week 12 and Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epicardial fat, diabetes, dapagliflozin