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Empagliflozin for Obesity-Related Heart Disease
Study Summary
This trial will study if a drug can reduce inflammation in obese patients to decrease their risk of cardiovascular disease.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 1 & 2 trial • 29 Patients • NCT04907214Trial Design
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- You have had a serious brain-related health issue like a stroke or bleeding in the brain.You have a history of severe liver disease with cirrhosis.Your kidney function, as measured by a specific equation, is below a certain level.You have a history of pancreas problems or surgery on the pancreas.You have a history of immune system or blood disorders.You have certain heart and blood vessel conditions, like heart attack, chest pain, irregular heartbeat, or problems with the heart's valves or muscles.You are taking long-term steroids or blood thinners.You have a body mass index (BMI) of 30 or higher.You must be between 18 and 70 years old.Your blood sugar levels are higher than normal.You have a history of drinking too much alcohol or using illegal drugs.You have a serious stomach or intestine problem that could make it hard for the drug to work in your body.You have type 1 or type 2 diabetes, as confirmed by specific glucose levels or the use of anti-diabetic medication.
- 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.
- Group 1: Empagliflozin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
Is this trial open to individuals of advanced age?
"To participate in this medical trial, patients must be between 18 and 70 years of age. There are 222 trials specifically targeting minors and 1033 studies for seniors over 65."
What has been the primary purpose for which Empagliflozin is prescribed?
"Empagliflozin is commonly prescribed to treat a range of cardiovascular diseases, including congestive heart failure and type 2 diabetes. Additionally, it has been linked to reduced mortality from cardiovascular issues."
What prior research has been done concerning Empagliflozin's efficacy?
"At present, 45 clinical trials of empagliflozin are taking place with 13 in the final stage. While Sofia and North carolina serve as two major hubs for this research, a total of 935 sites worldwide have studies underway for Empagliflozin."
Is this innovative clinical trial unprecedented in its field?
"Empagliflozin is the subject of 45 live clinical trials taking place in 225 cities and 38 countries. This drug's research journey began 2018, when Boehringer Ingelheim sponsored its first study with 120 participants to complete Phase 3 approval. In the ensuing years since then, a total 178 additional studies have been completed."
What qualifications must a person possess to be eligible for this research project?
"This clinical trial seeks 17 participants aged 18-70 who suffer from obesity, impaired glucose tolerance or fasting glucose levels between 100 and 125mg/dL, Hemoglobin A1c (HbA1C) values ranging from 5.7 to 6.4%, and a body mass index of at least 30 kg/M2; additionally, all potential subjects must provide informed consent prior to enrollment."
What key goals does this investigation seek to accomplish?
"This research study has two primary goals. The first is to measure the Change in Flow-mediated Dilation After 3 Months, which will take place over a period of 12 weeks. Secondary ambitions include determining the Change in Plasma Inflammatory Cytokine IL-6 and other proinflammatory cytokines after three months, as well as measuringChange in Adipose Pro-Inflammatory T Cell Numbers during fortnightly assessments."
Is the application window for this experiment still available?
"Unfortunately, this research project is not currently enrolling patients. The trial was uploaded to the clinicaltrials.gov database on July 29th 2021 and last modified on January 11th 2023. For those seeking alternative studies, there are 1,470 obesity-related trials recruiting volunteers and 45 for Empagliflozin actively searching for candidates."
How many test subjects are engaging in this research project?
"Unfortunately, this research project is not currently accepting new enrolments. Initially posted on July 29th 2021 and last updated on January 11th 2023, the trial has ceased recruitment for now. That said, if you are looking to participate in other clinical trials there are 1470 studies related to obesity taking patients and 45 relating to Empagliflozin seeking volunteers."
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