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Empagliflozin for Obesity-Related Inflammation (SADIE2 Trial)
SADIE2 Trial Summary
This trial will study if an anti-diabetes drug can reduce inflammation in obese people, which could help prevent heart disease.
SADIE2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSADIE2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SADIE2 Trial Design
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Who is running the clinical trial?
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- My diabetes is not well-managed, with an HbA1c level of 9% or higher.I am not pregnant or breastfeeding and use effective birth control or am surgically sterilized.I have advanced liver disease with cirrhosis.I have only used metformin or a sulfonylurea for my diabetes in the last month.My kidney function, measured by eGFR, is below 45 mL/min/1.73 m2.You have a heart device like a pacemaker or defibrillator implanted.I have had a serious brain condition like a stroke or mini-stroke.You have three or more of the following: high blood pressure, high triglycerides, low HDL cholesterol, high blood sugar, or a large waist size.I have been on long-term steroid treatment for more than a week in the past month.I have not had a heart attack or serious heart issues in the last 6 months.I have a stomach or bowel problem that affects how medicines work in my body.Criterion Related to Known Adverse Effects of Drug: You have specific medical conditions or history of reactions that could be made worse by the study medications, including certain infections, urinary tract issues, blood pressure problems, and allergies to the trial medications or similar products.I have had pancreatitis or surgery on my pancreas.You have Type 1 diabetes.I have taken an SGLT2 inhibitor in the past 3 months.I am currently taking blood thinners.I understand the details and risks of the study.I don't have any health conditions that my medication can't control during the study.I have a history of immune or blood disorders.I am between 18 and 70 years old.You have a history of drinking more than 14 alcoholic drinks per week (for men) or more than 7 alcoholic drinks per week (for women), or using illegal drugs.I have not taken any GLP-1 receptor agonist drugs in the last 3 months.
- Group 1: Placebo Arm
- Group 2: Empagliflozin Arm
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How can I become a participant in this research study?
"This clinical trial has a set of eligibility criteria that must be met; chiefly, candidates must have obesity and fall within the 18 to 70 age range. 74 patients are required for this study to proceed."
Does this research study accept those aged 70 and above?
"According to the eligibility requirements, patients wishing to participate must be between 18 and 70 years old. There are 220 clinical trials for young individuals below 18 and 938 studies targeting elderly persons aged 65 or above."
Are new participants still being enrolled into this clinical research?
"Currently, this medical trial is not recruiting patients. According to clinicaltrials.gov, the study was initially posted on September 30th 2023 and its last update occurred in July 24th of the same year. However, 1404 other trials are presently seeking volunteers for their research."
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