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

The MERIT clinical trial is a two-year trial for participants ages between 21-65, with a BMI of 30-40, with type-2 diabetes and/or hypertension.

Brigham and Women's Hospital High Blood Pressure Diabetes Obesity
23 visits over 24 months
Estimated Time Commitment
Any Sex/Gender, 21-65 years
May Be Eligible
Payment up to $900
May Be Offered
Blood draw, Endoscopy, Medication, Office visit, Sedation, Overnight stay
May Be Required
 
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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. 

Principal Investigator

Christopher C Thompson, MD

Brigham and Women's Hospital

Public Profile

Who can participate


  • Patients aged between 21-65

  • Patients with BMI 30-40

  • Patients with type-2 diabetes and/or hypertension

  • Additional criteria based on lab tests

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
• 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


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. 


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

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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

ClinicalTrials.gov Identifier

NCT03406975


Participating Institutions


Funding Source

  • Industry
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