Appetite Suppression / Hormone Study Control Group (NCT02029677) | Clinical Trial Compass
UnknownNot Applicable
Appetite Suppression / Hormone Study Control Group
United States10 participantsStarted 2008-09
Plain-language summary
The purpose of this research study is to determine how changes in levels of obesity-related hormones in the gastrointestinal tract following Laparoscopic Adjustable Gastric Banding (LAGB) surgery may lead to a decrease in appetite and weight loss. Learning exactly how the Lap Band works may help us to develop new, less invasive treatments for morbid obesity. This knowledge may also lead to the development of preventive, cost-effective treatment strategies. As a control subject, participants will provide a comparison for changes in these hormones with medical weight loss compared to weight loss after LAGB surgery.
Who can participate
Age range
18 Years – 69 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:
* Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2
* Age great than or equal to 18 years and less than 70 years
* Able to provide informed consent
* If female with reproductive potential, agrees to use a reliable method of birth control for the duration of the study (6 months)
Exclusion Criteria:
* Enrolled in another clinical study which involves an investigational drug
* Any condition where protocol compliance is unlikely (e.g. anxiety disorder, inadequate comprehension)
* Pregnancy
* Previous gastric or esophageal surgery
* Immunosuppressive drugs including corticosteroids
* Type 2 diabetes
* Coagulopathy (INR \> 1.5 or platelets \< 100,00/ul)
* Anemia (Hgh \< 10.0 g/dl)
* Any contraindication to treatment
* A severe concurrent illness likely to limit life (e.g. cancer)
* Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
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
1
Hormonal Mechanism of Action for Weight Loss
Timeframe: Preoperatively (baseline) and at 1-, 3- and 6-months post-surgery