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

NCT04306445 | Unknown FDA Device

• 1 other identifier: 19-0278
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  10%TBWL by GI-IGB, ESG, or Medically Supervised MRP

  6 months

Secondary Outcomes (5)

• Gastric emptying measured by technetium 99 gastric emptying study

  6 months

• Acyl-Ghrelin measured at multiple times points during a mixed meal test (MMT)

  6 months

• Glucose measured at multiple times points during a mixed meal test (MMT)

  6 months

• Insulin measured at multiple times points during a mixed meal test (MMT)

  6 months

• Level of hunger measured using a visual analog scale (Hunger VAS)

  6 months

Study Arms (3)

GF-IGB: Obalon Balloon

ACTIVE COMPARATOR

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.

Device: GF-IGB: Obalon Balloon

Medically Supervised Meal Replacement Program: My New Weigh

ACTIVE COMPARATOR

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.

Dietary Supplement: Medically Supervised Meal Replacement Program: My New Weigh

Endoscopic Sleeve Gastroplasty: ESG

ACTIVE COMPARATOR

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.

Procedure: Endoscopic sleeve gastroplasty: (ESG)

Interventions

GF-IGB: Obalon Balloon DEVICE

The balloon, which is attached to a thin catheter, is swallowed by the patient in a standing position. Once the two-step verification of balloon passage into the stomach by both fluoroscopy and pressure reading, the balloon is inflated to a volume of 250 ml with a nitrogen-mix gas, additional imaging of the inflated balloon is obtained, the catheter is ejected from the balloon, and the catheter is pulled out through the patient's mouth. The process is repeated at week 2 for the second balloon and between weeks 4-8 for the third balloon. All patients are given an individualized calorie prescription by a registered dietitian for a goal of up to 2 pounds of weight loss per week. The balloons are removed endoscopically 6 months after placement of the first balloon. Patients also attend monthly virtual individual diet coaching and monthly virtual group behavior coaching sessions both delivered by a registered dietitian for twelve months focused on long-term behavior change.

GF-IGB: Obalon Balloon

Medically Supervised Meal Replacement Program: My New Weigh DIETARY_SUPPLEMENT

Patients are given an individualized calorie prescription by a registered dietitian for a goal of 2 pounds weight loss per week. Patients are seen in a group-based program once a week focused on long-term behavior change and use meal replacements for a nutritionally balanced very low-calorie diet for 20 weeks. 4-5 meal replacements are consumed per day. If only 4 meal replacements are consumed, individuals eat 3 servings of vegetables and 2 servings of fruit per day as well.

Medically Supervised Meal Replacement Program: My New Weigh

Endoscopic sleeve gastroplasty: (ESG) PROCEDURE

Endoscopic sleeve gastroplasty is a weight loss procedure that uses an FDA 510K cleared endoscopic suturing device known as Overstitch to reduce the size of the gastric body. The procedure is completed with an endoscope. It is inserted through the mouth, down the esophagus, and into the stomach. Sutures with 8-10 bites 1.5-2 cm apart in a U-shape pattern are placed starting distally 6 cm proximal to the pylorus. Additional sutures are placed moving proximally up to 2 cm distal to the gastroesophageal junction. An additional row of sutures is then placed again in the distal to proximal stomach to complete the gastroplasty. All patients are given an individualized calorie prescription by a registered dietitian for a goal of up to 2 pounds of weight loss per week. Patients also attend monthly virtual individual diet coaching and monthly virtual group behavior coaching sessions both delivered by a registered dietitian for twelve months focused on long-term behavior change.

Endoscopic Sleeve Gastroplasty: ESG

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (27)

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  BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shelby Sullivan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelby Sullivan, MD

CONTACT

303-724-0017; shelby.sullivan@cuanschutz.edu

Janelle Medernach, MS, RDN

CONTACT

303-724-6070; janelle.medernach@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 13, 2020
• Study Start: March 2, 2020
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)