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Intragastric Balloons & Endoscopic Sleeve vs Meal Replacement for Obesity
N/A
Waitlist Available
Led By Shelby Sullivan, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female participants aged 22-65
Initiating treatment with GF-IGB, ESG, or medically supervised MRP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing the effects of three different obesity treatments on gastric emptying, hormone levels, and hunger.
Who is the study for?
This trial is for adults aged 22-65 with a BMI of 30-40 who have been weight stable in the last three months. It's not for those with liver, thyroid, or uncontrolled depression issues; diabetes; anemia; past bariatric surgery; recent use of weight loss meds; gastroparesis; pregnancy or lactation, non-English speakers, decisionally challenged individuals, or allergies to meal components used in tests.Check my eligibility
What is being tested?
The study compares the effects of a gas-filled intragastric balloon (GF-IGB), endoscopic sleeve gastroplasty (ESG), and a medically supervised meal replacement program on hunger sensations, hunger hormones levels, and how quickly the stomach empties after eating.See study design
What are the potential side effects?
Potential side effects may include discomfort from the balloon or ESG procedure, changes in digestion speed which could affect bowel movements and nutrient absorption. The meal replacements might cause digestive adjustments like bloating or constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 65 years old.
Select...
I am starting treatment with GF-IGB, ESG, or a medically supervised MRP.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight Loss
Secondary outcome measures
Acyl-Ghrelin measured at multiple times points during a mixed meal test (MMT)
Gastric emptying measured by technetium 99 gastric emptying study
Glucose measured at multiple times points during a mixed meal test (MMT)
+2 moreTrial Design
3Treatment groups
Active Control
Group I: GF-IGB: Obalon BalloonActive Control1 Intervention
Obalon balloons are gas-filled balloons used for weight loss by taking up more space in the stomach. There are three separate balloons that are placed. They are inflated once the capsules containing the balloons are swallowed. The second balloon is swallowed two weeks after the first balloon, and the third balloon is swallowed four to eight weeks after the second balloon. All three balloons are removed six months after the first balloon is placed.
Group II: Medically Supervised Meal Replacement Program: My New WeighActive Control1 Intervention
Meal Replacements are used for weight loss in order to achieve a very low-calorie diet that is nutritionally balanced. Four to five meal replacements are consumed per day. If only four meal replacements are consumed per day, three servings of vegetables and two servings of fruit are consumed as well. This program lasts for about five months or twenty weeks.
Group III: Endoscopic Sleeve Gastroplasty: ESGActive Control1 Intervention
Endoscopic sleeve gastroplasty (ESG) is a weight loss procedure that uses an endoscopic suturing device known as Overstitch to reduce the size of the stomach. This decreases the amount of food one can consume, which leads to the consumption of fewer calories throughout the day, resulting in weight loss.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,451 Total Patients Enrolled
100 Trials studying Obesity
213,634 Patients Enrolled for Obesity
Shelby Sullivan, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
79 Total Patients Enrolled
2 Trials studying Obesity
79 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of anemia.I have a history of diabetes.I have controlled depression with a PHQ-9 score less than 10.I have not taken weight loss medications in the last 3 months.I have had weight loss surgery in the past.I am not pregnant or breastfeeding.I have difficulty making decisions due to a cognitive or mental health condition.I am between 22 and 65 years old.I have a history of liver disease.I have a history of delayed stomach emptying.I have a history of thyroid disease that is not well-controlled.I am starting treatment with GF-IGB, ESG, or a medically supervised MRP.
Research Study Groups:
This trial has the following groups:- Group 1: GF-IGB: Obalon Balloon
- Group 2: Medically Supervised Meal Replacement Program: My New Weigh
- Group 3: Endoscopic Sleeve Gastroplasty: ESG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can this clinical trial accommodate?
"Affirmative. According to the information published on clinicaltrials.gov, this medical experiment has been open since March 2nd 2020 and was recently revised on April 21st 2022. 75 participants are being sought from a single location for enrolment in the study."
Answered by AI
What are the criteria for eligibility in this research program?
"To qualify for this medical trial, applicants must be between 22 and 65 years old and possess a body mass index (BMI) classifying them as obese. The study is eyeing 75 participants in total."
Answered by AI
Are there any remaining slots available for prospective participants in this clinical trial?
"Affirmative. According to the details available on clinicaltrials.gov, this medical study is actively seeking participants since it was first posted in March 2nd 2020 and most recently updated in April 21st 2022. The trial requires 75 volunteers from one site."
Answered by AI
Does this clinical assessment accept participants aged 80 or higher?
"This research requires volunteers between the ages of 22 to 65. For those younger than 18, 202 other trials are available; for seniors over 65, 596 clinical studies exist."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Colorado
How old are they?
18 - 65
65+
What site did they apply to?
University of Colorado
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I was on Mounjaro from August -December 2022 and lost 60 pounds. I had to quit Mounjaro as our insurance changed and could not afford full price for the injections. With the advice of Dr Nicklas, looking for other ways for weight loss.
PatientReceived 2+ prior treatments
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