TerminatedNot Applicable

How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements

Stopped: The Principal Investigator left the University of Colorado

United States3 participantsStarted 2020-03-02

Plain-language summary

The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index \>30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Rates of successful obesity treatment with weight loss and weight maintenance remain low. Several endoscopic bariatric therapies and procedures have been approved for use in the United States, including three intragastric balloon systems (2 fluid-filled and one gas-filled) and endoscopic sleeve gastroplasty (ESG), both of which have lower risks than bariatric surgery and do not alter gastrointestinal anatomy. Weight loss with all intragastric balloons and ESG is higher than lifestyle therapy or weight loss medications, but less than bariatric surgery. Unlike weight loss medications where weight loss from the medication is regained within 6-8 months after therapy ends, weight loss maintenance with intragastric balloons remains high with 66-88.5% of the weight loss maintained 6 months after device removal. Data suggests that space occupying devices with a volume of 400 ml or more in the stomach increase feelings of fullness and result in weight loss, but this does not explain the prolonged effect of weight loss maintenance after balloon removal. Although few studies have investigated the mechanism of action of fluid-filled balloons and one study with 4 patients undergoing ESG on weight loss, these data suggest that gastric emptying as well as space occupation contribute to weight loss. However, no studies have investigated the mechanisms of action of gas filled intragastric balloons on weight loss. Understanding the mechanisms responsible for weight loss with the gas filled intragastric balloon system and ESG as well as any weight loss independent effects on blood glucose control would lay the groundwork for studies evaluating predictors of response to improve patient selection as well as studies understanding the mechanisms behind weight loss maintenance and developing strategies to prolong weight loss maintenance. Therefore, the purpose of this pilot study is to determine the effects 10% total body weight loss (%TBWL) in patients with obesity treated with the intragastric balloon (GF- IGB) system or ESG compared to patients with obesity treated with a meal replacement program (MRP) on 1) gastric emptying, 2) hormonal adaptation to weight loss and 3) hunger.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female participants aged 22-65 * Weight Stable (\<5% weight change in the last 3 months) * Initiating treatment with GF-IGB, ESG, or medically supervised MRP * BMI of 30-40 Exclusion Criteria: * History of liver disease * History of uncontrolled thyroid disease * History of anemia * History of diabetes * History of eating disorder * History of uncontrolled depression defined as a score of ≥ 10 on PHQ-9 (Patient Health Questionnaire-9) * Use of weight loss medications in the past 3 months * History of gastroparesis * History of bariatric surgery * History to allergy or intolerance to any component of the meal used in the gastric emptying study or mixed meal test * Women who are pregnant or lactating * Currently incarcerated * Non English speaking * Decisionally challenged adults

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight Loss

Timeframe: 6 months

Trial details

NCT IDNCT04306445

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-22

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