Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criterias

If female with reproductive potential, agrees to use a reliable method of birth control for the duration of the study (6 months)
Age great than or equal to 18 years and less than 70 years
Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2
...
If female with reproductive potential, agrees to use a reliable method of birth control for the duration of the study (6 months)
Age great than or equal to 18 years and less than 70 years
Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2
Able to provide informed consent

Exclusion Criterias

Pregnancy
Enrolled in another clinical study which involves an investigational drug
Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
...
Pregnancy
Enrolled in another clinical study which involves an investigational drug
Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
Anemia (Hgh < 10.0 g/dl)
Coagulopathy (INR > 1.5 or platelets < 100,00/ul)
Type 2 diabetes
Any contraindication to treatment
Immunosuppressive drugs including corticosteroids
Any condition where protocol compliance is unlikely (e.g. anxiety disorder, inadequate comprehension)
Previous gastric or esophageal surgery
A severe concurrent illness likely to limit life (e.g. cancer)

Summary

Conditions
  • Bariatric Surgery Patient
  • Morbid Obesity
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 69 years
Gender
Both males and females

Description

The expected duration of participation in the study is up to 6 months before bariatric surgery depending on participants' weight loss and insurance company requirements. A total of 10 patients will take part in this control group. The following procedures and tests will be done before surgery: routi...

The expected duration of participation in the study is up to 6 months before bariatric surgery depending on participants' weight loss and insurance company requirements. A total of 10 patients will take part in this control group. The following procedures and tests will be done before surgery: routine standard tests required to be involved in the obesity surgery program (history and physical, blood work, ECG, nutritional assessment, psychological assessment and sleep study). During preoperative evaluation participants will be started on a medical weight loss diet with instructions provided by the program's endocrinologist, nurse practitioners and dietitians with the weight loss goals as stipulated by insurance companies and have a series of additional laboratory tests (blood work) done to test the hormonal response to weight loss. This blood work, which is drawn after eating a standardized meal, is the only experimental procedure of the entire study. We will be measuring several hormones associated with obesity including ghrelin, obestatin, peptide tyrosine tyrosine (PYY3-36), adiponectin, Glucagon-like peptide-1 (GLP-1), oxyntomodulin, leptin, insulin, glucose and pancreatic polypeptide (PP). Measurements will be done at 4 time intervals before surgery: at enrollment, +1-month, +3-months, and +6-months. This will allow us to look at hormone levels as participants gradually lose weight. If a participant reaches the insurance-dictated weight loss before 6 months, study participation will cease to allow the individual to proceed with surgery scheduling. Participants will be required to fast overnight prior to each visit. An intravenous line will be placed at 0800, all subjects will be fed a standard breakfast (35% fat, 15% protein, and 50% carbohydrate) consisting of 25% of estimated caloric needs for weight maintenance, which they will consume in 30 minutes or less. Blood will be taken beginning 30 minutes before the standardized meal, then at time 0, then 30, 60, 90, and 120 minutes after the meal for total ghrelin, pancreatic polypeptide, PYY3-36, active GLP-1, insulin, glucagon, leptin, oxyntomodulin, and glucose. An extra fasting sample will be obtained for lipids and total adiponectin. Three-quarters of a cup (148 mL) of blood will be drawn for analysis at each visit. Additionally, subjects will be asked to complete a Visual Analog Scale (VAS) three times during each research visit by placing a single vertical mark across a 100 mm in length line, with words anchored at each end, expressing the most positive and the most negative rating, to assess hunger, satiety, and fullness. Each visit will last approximately 4 hours.

Inclusion Criterias

If female with reproductive potential, agrees to use a reliable method of birth control for the duration of the study (6 months)
Age great than or equal to 18 years and less than 70 years
Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2
...
If female with reproductive potential, agrees to use a reliable method of birth control for the duration of the study (6 months)
Age great than or equal to 18 years and less than 70 years
Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2
Able to provide informed consent

Exclusion Criterias

Pregnancy
Enrolled in another clinical study which involves an investigational drug
Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
...
Pregnancy
Enrolled in another clinical study which involves an investigational drug
Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn's disease)
Anemia (Hgh < 10.0 g/dl)
Coagulopathy (INR > 1.5 or platelets < 100,00/ul)
Type 2 diabetes
Any contraindication to treatment
Immunosuppressive drugs including corticosteroids
Any condition where protocol compliance is unlikely (e.g. anxiety disorder, inadequate comprehension)
Previous gastric or esophageal surgery
A severe concurrent illness likely to limit life (e.g. cancer)

Locations

Portland, Oregon, 97232
Portland, Oregon, 97232

Tracking Information

NCT #
NCT02029677
Collaborators
  • Legacy Health System
  • Allergan
Investigators
  • Principal Investigator: Emma J Patterson, MD Oregon Weight Loss Surgery
  • Emma J Patterson, MD Oregon Weight Loss Surgery