MERIT Trial Offers New Weight Loss Opportunity
Often in spite of diet, exercise and lifestyle changes, some folks with hypertension or type 2 diabetes face a stubborn amount of weight that just won’t budge.
A new clinical trial involving weight-loss procedures may offer help.
Members of the Avera McKennan Bariatric Institute seek individuals meeting the study’s criteria to consider participating in the Multi-Center Endoscopic Sleeve Gastroplasty Randomized Intervention Trial, or MERIT.
“This trial really is for people who want to lose 40-60 pounds and who have tried – and failed – to lose that weight in other ways,” said Andrea Hanson, MS, RDN, LN, a bariatric dietitian with the Avera McKennan Bariatric Institute.
How the Trial Works
MERIT is a two-year trial of 25 participants, who are randomly place into two groups. Qualified participants in the control group receive weight-loss counseling and guidance. After the first year, they have the option of receiving an endoscopic sleeve gastroplasty procedure. Trial group participants will have the procedure initially, and work with the bariatric team for supportive guidance in weight-loss behaviors for the trial’s duration.
“Every participant enrolled in the trial has the opportunity to have the procedure, given that all qualifications are met,” said Bariatric Program Manager Kim McCoy, RN, CBM. “Participation requires someone willing to commit fully to the program, its monthly follow-ups and all the other steps that make the clinical trial what it is. It’s not an easy path, but it is one that we hope can be effective.”
Fitting the Guidelines
To be eligible participants, individuals should be diagnosed with type 2 diabetes or hypertension, with a BMI of 30-40. They should be between the ages of 21-65. They also must take medication to treat either their high blood pressure or diabetes, and commit to ongoing study appointments in Sioux Falls.
“Qualified participants will pay only for the protein meal replacements we recommend, as well as vitamins,” said Hanson. “The counseling, procedure and other medical costs related to the trial are covered by the grant funding that underwrites our effort in this study.”
Brad Thaemert, MD, FACS, serves as the primary physician for the study. The study’s overarching goal is to determine the effectiveness of this procedure and accompanying counseling as a weight-loss tool. Most insurance programs currently do not cover the cost of the procedure.
“We have had strong interest in the program,” McCoy said. “While this study might not be the right fit for every person, we encourage anyone who meets the basic conditions to contact us.”
Call 605-322-1194 to learn more about the trial.