Morbid ObesityNCT01341028
Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection
A study testing Roux-en-Y gastric bypass (LRYGBP) and LRYGBP+gastric fundus resection in people with Morbid Obesity, run by University of Patras at 1 site in Greece.
Trial summary
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented. Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Roux-en-Y gastric bypass (LRYGBP) and LRYGBP+gastric fundus resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- May 2007to Jun 2010
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index higher than 40 kg/m2
Who cannot join
- pregnancy
- diabetes mellitus
- substance abuse
- chronic medical or psychiatric illness
- previous gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Resection of the Gastric Fundus on the Secretion of Ghrelin, Peptide-YY, Glucagon-like Peptide-1 and Insulin Secretion in Morbidly Obese Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
- Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented.
- Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of appetite caused by the release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food intake.
- In the present study the investigators sought to evaluate the effects of the resection of the gastric fundus, the main source of ghrelin production, on the secretion of ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.
Read the detailed description
Twenty four patients were included prospectively in the study. After randomization, 12 patients underwent LRYGBP and 12 LRYGBP plus gastric fundus resection (LRYGBP+FR).
All human studies were performed according to the principles of the Declaration of Helsinki. The local Research and Ethics Commitee at the University Hospital of Patras approved the study. Written informed consent was obtained from all patients.
All the operations were performed by the same surgeon laparoscopically. The RYGBP procedures were performed creating a small isolated lesser curve-based gastric pouch (20 ± 5 ml) and a 150cm Roux limb. The gastroenteroanastomosis was conducted with a 25 mm circular stapler. The dissection of the fundus of the stomach in the (LRYGBP+FR) group was done with the use of EndoGia No 60.
The subjects were studied before and at 3, 6 and 12 months after the operation. All the patients underwent an oral glucose tolerance test (OGTT) with 75 g glucose, preoperatively. In addition, venous blood was collected after an overnight 12 hour fast and 30, 60 and 120 min after the administration of a 300 kcal mixed meal.The meal was consumed in ten minutes and consisted of 18% protein, 55% carbohydrate and 27% fat (Resource energy drink, Nestle Nutrition, France). Plasma levels of PYY, GLP-1, ghrelin and insulin were determined at every time point of the study. All patients underwent complete clinical evaluation during follow-up including nutritional, behavioral and anthropometric parameters. Visual analogue scales (VAS) were used to measure hunger, nausea, fullness and aversion to food, before and 30, 60 and 120 min after the consumption of the meal. Weight loss evaluation was based on postope¬rative body weight, body mass index (BMI) and % excess weight loss (EWL %).
Insulin resistance was approximated using the homeostatic model assessment for insulin resistance (HOMA IR). The following formula was used in its calculation:
HOMA IR = (fasting glucose [mmole] /lt X fasting insulin [μU/ml])/22.5). The insulinogenic index, a commonly used indicator of pancreatic β-cell function, was calculated as the ratio of increment of insulin concentrations to that of glucose concentrations at 30 minutes after meal ingestion (Δ [ins30 - ins0] / Δ [Glu30 -Glu0]).
- Conditions
- Morbid Obesity
- Being tested
- Roux-en-Y gastric bypass (LRYGBP), LRYGBP+gastric fundus resection
- Keywords
- weight loss, appetite, ghrelin, PYY, GLP-1, insulin, laparoscopic, Roux-en-Y gastric bypass, gastric fundus resection
- Medical subject headings
- Obesity, Morbid, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass (LRYGBP)Procedure or surgery
Also called LRYGBP
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass
LRYGBP+gastric fundus resectionProcedure or surgery
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass (LRYGBP) | Active comparator | Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass Receives: Procedure: Roux-en-Y gastric bypass (LRYGBP) |
| LRYGBP plus gastric fundus resection | Experimental | Twelve patients underwent laparoscopic Roux-en-Y gastric bypass plus gastric fundus resection Receives: Procedure: LRYGBP+gastric fundus resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin.
The effect on the secretion of ghrelin, PYY, GLP-1 and insulin
Measured: The outcome was assessed 12 months after the operation
Secondary outcomes (1)
The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss
The effect of fundus resection on glucose levels, appetite and weight loss was assessed 12 months after the operation
Measured: At 12 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionJun 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Investigators
- Theodore K Alexandrides, Principal investigator, Professor of Medicine, School of Medicine, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341028
- Sponsor's protocol ID
- RYGBPFR001
- Status last verified
- Feb 2007
- First submitted
- 18 Apr 2011
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Resection of the Gastric Fundus on the Secretion of Ghrelin, Peptide-YY, Glucagon-like Peptide-1 and Insulin Secretion in Morbidly Obese Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01341028
- Acronym / sponsor ID
- RYGBPFR001
- Conditions
- Morbid Obesity
- Keywords
- weight loss, appetite, ghrelin, PYY, GLP-1, insulin, laparoscopic, Roux-en-Y gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Apr 2011 (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.
- Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented.
- Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of appetite caused by the release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food intake.
- In the present study the investigators sought to evaluate the effects of the resection of the gastric fundus, the main source of ghrelin production, on the secretion of ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.
Detailed description
Twenty four patients were included prospectively in the study. After randomization, 12 patients underwent LRYGBP and 12 LRYGBP plus gastric fundus resection (LRYGBP+FR).
All human studies were performed according to the principles of the Declaration of Helsinki. The local Research and Ethics Commitee at the University Hospital of Patras approved the study. Written informed consent was obtained from all patients.
All the operations were performed by the same surgeon laparoscopically. The RYGBP procedures were performed creating a small isolated lesser curve-based gastric pouch (20 ± 5 ml) and a 150cm Roux limb. The gastroenteroanastomosis was conducted with a 25 mm circular stapler. The dissection of the fundus of the stomach in the (LRYGBP+FR) group was done with the use of EndoGia No 60.
The subjects were studied before and at 3, 6 and 12 months after the operation. All the patients underwent an oral glucose tolerance test (OGTT) with 75 g glucose, preoperatively. In addition, venous blood was collected after an overnight 12 hour fast and 30, 60 and 120 min after the administration of a 300 kcal mixed meal.The meal was consumed in ten minutes and consisted of 18% protein, 55% carbohydrate and 27% fat (Resource energy drink, Nestle Nutrition, France). Plasma levels of PYY, GLP-1, ghrelin and insulin were determined at every time point of the study. All patients underwent complete clinical evaluation during follow-up including nutritional, behavioral and anthropometric parameters. Visual analogue scales (VAS) were used to measure hunger, nausea, fullness and aversion to food, before and 30, 60 and 120 min after the consumption of the meal. Weight loss evaluation was based on postope¬rative body weight, body mass index (BMI) and % excess weight loss (EWL %).
Insulin resistance was approximated using the homeostatic model assessment for insulin resistance (HOMA IR). The following formula was used in its calculation:
HOMA IR = (fasting glucose [mmole] /lt X fasting insulin [μU/ml])/22.5). The insulinogenic index, a commonly used indicator of pancreatic β-cell function, was calculated as the ratio of increment of insulin concentrations to that of glucose concentrations at 30 minutes after meal ingestion (Δ [ins30 - ins0] / Δ [Glu30 -Glu0]).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass (LRYGBP) | Active comparator | Procedure: Roux-en-Y gastric bypass (LRYGBP)Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass |
| LRYGBP plus gastric fundus resection | Experimental | Procedure: LRYGBP+gastric fundus resectionTwelve patients underwent laparoscopic Roux-en-Y gastric bypass plus gastric fundus resection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index higher than 40 kg/m2
Key exclusion criteria (5 listed)
- pregnancy
- diabetes mellitus
- substance abuse
- chronic medical or psychiatric illness
- previous gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass (LRYGBP)Also: LRYGBPTwelve patients underwent laparoscopic Roux-en-Y gastric bypass | Procedure or surgery | Roux-en-Y gastric bypass (LRYGBP) |
| LRYGBP+gastric fundus resectionTwelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection | Procedure or surgery | LRYGBP plus gastric fundus resection |
Primary outcome
The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin.
Time frame: The outcome was assessed 12 months after the operation
The effect on the secretion of ghrelin, PYY, GLP-1 and insulin
1 secondary outcome
The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss
Time frame: At 12 months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Theodore K Alexandrides principal investigator
Professor of Medicine, School of Medicine, University of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass (LRYGBP) and LRYGBP+gastric fundus resection in people with Morbid Obesity, run by University of Patras at 1 site in Greece.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 25 Apr 2011. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin. (time frame: The outcome was assessed 12 months after the operation). 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 25 Apr 2011.