Appetite Suppression / Hormone Study Control Group

NCT02029677 | Active Not Recruiting

• 1 other identifier: FWA00001280
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity; Bariatric Surgery Patient

Outcome Measures

Primary Outcomes (1)

• Hormonal Mechanism of Action for Weight Loss

  Our primary outcome measures the mechanism of action of the adjustable band in producing weight loss from the time of surgery to visit timepoints at plus one, 3 and six months following LAGB placement. Changes in appetite and hunger will be measured in the form of a validated clinical analogue scale from baseline to 1, 3 and 6 months post-surgery. Statistical analysis will be performed to look for changes in blood levels of gut hormones (total ghrelin, PYY3-36, total adiponectin, active GLP-1, glucose, glucagon, insulin, leptin, oxyntomodulin, and pancreatic polypeptide) measured before and after a standardized meal from baseline values to 1, 3, and 6 months post-surgery.

  Preoperatively (baseline) and at 1-, 3- and 6-months post-surgery

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with morbid obesity or severe obesity with comorbidities who meet the National Institutes of Health criteria for bariatric surgery and required by insurance to participate in a medically supervised weight loss program prior to authorization for surgery will be offered enrollment into the study. The 10 subjects enrolled will be men and women ages 18 to 69 years with a BMI of greater than or equal to 35 kg/m2 and less than 60 kg/m2. Patients must be fit to undergo major abdominal surgery and be reasonably expected to complete the six-month study protocol prior to authorization for surgery.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Weight Loss Surgery, LLC: lead
• Legacy Health System: collaborator
• Allergan: collaborator

Study Sites (1)

Oregon Weight Loss Surgery

Portland, Oregon, 97232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each time these hormone assays are performed, aliquots of plasma will be frozen at -80C: * Total immunoreactive ghrelin - Plasma will be assayed in duplicate for immunoreactive ghrelin concentration using a commercial radioimmunoassay (RIA) * Lipids - Plasma total cholesterol, TG, HDL-C, and LDL-C will be measured * Glucose and insulin - Plasma glucose concentrations will be measured in triplicate using the glucose oxidase method. Plasma insulin will be measured in duplicate using a modification of a double antibody radioimmunoassay * Adiponectin and other gut hormones - Adiponectin, PYY3,36 and GLP-1 will be measured using a commercial RIA. Pancreatic polypeptide (PP) will be measured using a commercial RIA

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Emma J Patterson, MD

  Oregon Weight Loss Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emma Patterson, M.D.

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 8, 2014
• Study Start: September 1, 2008
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (1)