Appetite Suppression / Hormone Study Control Group
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|ClinicalTrials.gov Identifier: NCT02029677|
Recruitment Status : Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : March 13, 2019
|Condition or disease|
|Morbid Obesity Bariatric Surgery Patient|
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 Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Putative Hormonal Mechanisms of Appetite Suppression Following LAGB: A Pilot Study|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
- 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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029677
|United States, Oregon|
|Oregon Weight Loss Surgery|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Emma J Patterson, MD||Oregon Weight Loss Surgery|