Status:
UNKNOWN
How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements
Lead Sponsor:
University of Colorado, Denver
Conditions:
Obesity
Eligibility:
All Genders
22-65 years
Phase:
NA
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 complication...
Detailed Description
Obesity is a chronic disease, which is associated with and contributes to multiple medical co- morbidities including but not limited to cardiovascular disease, diabetes, nonalcoholic fatty liver disea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04306445
Start Date
March 2 2020
End Date
March 2 2024
Last Update
April 25 2022
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045