Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Looking for Obese Patients with Hypertension or Diabetes for New Clinical Trial for Weight Loss
This project is not recruiting.
Overview
What we are studying
We are completing this study to compare how effective the Endoscopic Sleeve Gastroplasty (ESG) procedure is for achieving long-term weight loss in patients with hypertension and/or type-2 diabetes when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life.
Why it is important
More than one third of the U.S. adults are obese and there has been an increase in comorbid diseases, such as diabetes and hypertension. Patients with mild to moderate obesity (BMI 30-40) do not qualify for bariatric surgery, therefore, this procedure may be used in the future to fill the obesity management gap.
What we hope to accomplish
Participation in this trial may help support having this procedure covered by insurance plans for future patients.
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Principal Investigator
Who can participate
Who cannot participate
• Patients who have had previous endoscopic or bariatric procedures
• Females participants must not be pregnant or breastfeeding
• Additional medical history and laboratory data to be reviewed by study doctor
What you may be asked to do
At study visits, we may; • Ask you questions about yourself Based on your medical history, as well as your laboratory results from blood samples taken at visit 1, the study staff will let you know if you are a suitable candidate for this study. If you are eligible, you will be randomized to a treatment group or a lifestyle intervention group. Study visits will be carried out monthly for 2 years.
• Ask about your medical history
• Review your medication list
• Perform a physical exam, including blood pressure, pulse, body weight and height
• Perform an electrocardiogram (EKG - an electrical recording of your heart rate and rhythm)
• Draw blood for testing. If you are a woman of child-bearing potential, this will include a urine sample to test for pregnancy.
• Ask to answer questionnaires about your overall health and quality of life
Project activities may include:
- Blood draw
- Endoscopy
- Medication
- Office visit
- Sedation
- Overnight stay
Estimated Time Commitment
23 visits over 24 months
What You May Get
Enrolled participants will be compensated for their time and effort. Patients will receive $100 for every 4 consecutive visits attended.
Location
Brigham and Women's Hospital
45 Francis Street, Boston, MA 02115
Travel
- Parking available
- Accessible by public transportation
Travel and Parking Details
Self-parking is available at the 45 Francis street garage located below the hospital entrance at 45 Francis Street. Valet parking is available at both of the hospital’s Francis Street entrances, 45 Francis Street and 75 Francis Street.
Additional Information
Funding Source
- Industry