Morbid ObesityNCT02029677
Appetite Suppression / Hormone Study Control Group
An observational study of Morbid Obesity and Bariatric Surgery Patient, run by Oregon Weight Loss Surgery, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery Patient
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Putative Hormonal Mechanisms of Appetite Suppression Following LAGB: A Pilot Study
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.
Read the detailed 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: 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.
- Conditions
- Morbid Obesity, Bariatric Surgery Patient
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively (baseline) and at 1-, 3- and 6-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startSep 2008
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Weight Loss Surgery, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Legacy Health System, Allergan
- Responsible party
- Principal investigator, Emma Patterson, Oregon Weight Loss Surgery, LLC
- Investigators
- Emma J Patterson, MD, Principal investigator, Oregon Weight Loss Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029677
- Sponsor's protocol ID
- FWA00001280
- Status last verified
- May 2024
- First submitted
- 18 Dec 2013
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Putative Hormonal Mechanisms of Appetite Suppression Following LAGB: A Pilot Study
- ClinicalTrials.gov ID
- NCT02029677
- Acronym / sponsor ID
- FWA00001280
- Conditions
- Morbid Obesity, Bariatric Surgery Patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Weight Loss Surgery, LLCUniversity, hospital or other
- Collaborators
- Legacy Health System, Allergan
- Study start
- Sep 2008
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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: 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hormonal Mechanism of Action for Weight Loss
Time frame: Preoperatively (baseline) and at 1-, 3- and 6-months post-surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma J Patterson, MD principal investigator
Oregon Weight Loss Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Bariatric Surgery Patient, run by Oregon Weight Loss Surgery, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormonal Mechanism of Action for Weight Loss (time frame: Preoperatively (baseline) and at 1-, 3- and 6-months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.