The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function (NCT05972564) | Clinical Trial Compass
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
United States74 participantsStarted 2023-09-06
Plain-language summary
Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Age 18+ years old
ā. Metabolic syndrome as defined by 3 or more of 5 criteria:
ā. Systolic blood pressure ā„ 130 mmHg or diastolic blood pressure ā„ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month
ā. Triglycerides ā„ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)
ā. High-density lipoprotein (HDL) \< 40 mg/dL in males or \< 50 mg/dL in females
ā. Fasting blood glucose ā„ 100mg/dL or treatment with glucose-lowering medications
ā. Waist circumference ā„ 102 cm in males or ā„ 88cm in females
ā. BMI ā„ 35 kg/M2
Exclusion criteria
ā. Type 1 diabetes.
ā. Poorly controlled type 2 diabetes as defined by HbA1c ā„ 9%.
ā. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.
ā. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.
ā0. Treatment with an SGLT2 inhibitor in the last 3 months.
ā1. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone surgical sterilization or to be using an intra-uterine device, hormonal contraceptive, or barrier methods of birth control.
ā2. Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, -second- or third-degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
ā3. Presence of implanted cardiac defibrillator or pacemaker