Morbid ObesityNCT01806506
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
A study testing Laparoscopic sleeve gastrectomy and Roux-en-Y Gastric Bypass in people with Morbid Obesity and Metabolic Syndrome X, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Metabolic Syndrome X, Diabetes Mellitus
- What is being tested?
- Laparoscopic sleeve gastrectomy and Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2008to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI≥40 kg/m2
- BMI≥35 kg/m2 with at least one comorbidity associated with obesity
Who cannot join
- BMI > 60 kg/m2
- poorly controlled significant medical or psychiatric disorders
- active alcohol or substance abuse
- active duodenal/gastric ulcer disease
- difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
- previous major gastrointestinal surgery
- diagnosed or suspected malignancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of General, Transplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaaw
Warsaw, 02-097
About this study
Official title: Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.
Read the detailed description
Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is necessary. The former method is the established "gold standard" procedure with good outcomes reported in many studies. However it is much more complex and the learning curve is longer. The latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. It produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. Purely restrictive procedures such as LSG are theoretically less beneficial in this group of patients. In the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.
- Being tested
- Laparoscopic sleeve gastrectomy, Roux-en-Y Gastric Bypass
- Keywords
- Bariatric surgery, Gastric bypass, Sleeve gastrectomy, Weight loss, Lipoproteins, Insulin resistance, Incretins, Quality of life
- Medical subject headings
- Obesity, Morbid, Metabolic Syndrome, Diabetes Mellitus, Dyslipidemias, Hypertension, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie.
Roux-en-Y Gastric BypassProcedure or surgery
Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy. Receives: Procedure: Laparoscopic sleeve gastrectomy |
| Roux-en-Y Gastric Bypass | Experimental | The group of morbidly obese patients assigned to Roux-en-Y gastric bypass. Receives: Procedure: Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess Weight Loss From Baseline
Weight loss measured as a percentage of excess weight lost is one of the most commonly used and accepted outcome measure in clinical trials evaluating bariatric surgery.
Measured: 12 months after surgery
Secondary outcomes (26)
Number of Patients With Complications
Complications are defined as any negative deviation from the normal postoperative course. Complications of bariatric surgery include but are not limited to: gastrointestinal leak, intrabdominal bleeding, gastrointestinal bleeding, gastrointestinal stricture, gastrointestinal fistula, marginal ulceration, internal hernia, bowel obstruction, deep vein thrombosis, pulmonary embolism, wound infection, seroma, fascial dehiscence, abdominal hernia, gallstone formation, dehydration, nutritional deficiencies
Measured: 12 months after surgery
Comorbidities Prevalence Changes
Number of patients with comorbidities such as: type 2 diabetes mellitus, arterial hypertension, dyslipidemia, obstructive sleep apnea, degenerative arthritis, gallbladder disease, gastro-esophageal reflux disease.
Measured: Evaluation at baseline and 1, 6 and 12 months after surgery
Change in Weight From Baseline
Absolute weight loss (in kilograms) is evaluated. It is one of the most commonly used and accepted outcome measures in clinical trials evaluating bariatric surgery. It is more dependent on the initial weight of a study participant.
Measured: Evaluation at baseline and 12 months after surgery
Change in BMI From Baseline
Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.
Measured: Baseline and 12 months after surgery
Plasma Total Cholesterol at 12 Months
Fasting plasma total cholesterol concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma HDL at 12 Months
Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma LDL at 12 Months
Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma Triglycerides at 12 Months
Fasting plasma triglycerides concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma Glucose at 12 Months
Fasting plasma glucose concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma Insulin at 12 Months
Fasting plasma insulin concentration in patients 12 months after surgery.
Measured: 12 months after surgery
Plasma C-peptide at 12 Months
Fasting plasma C-peptide concentration in patients 12 months after surgery.
Measured: 12 months after surgery
HOMA Index at 12 Months
Insulin resistance (IR) measured with the homeostatic model assessment (HOMA) method. In the published studies the HOMA model correlated with estimates using the reference euglycemic clamp method. The following equation is used: HOMA-IR = (fasting plasma glucose concentration [mmol/L] x fasting plasma insulin concentration [miliunits/L])/22.5
Measured: 12 months after surgery
HbA1c at 12 Months
The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.
Measured: 12 months after surgery
Plasma CRP at 12 Months
C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk.
Measured: 12 months after surgery
Plasma Uric Acid at 12 Months
Hyperuricemia is associated with metabolic syndrome and obesity.
Measured: 12 months after surgery
Plasma Ghrelin at 12 Months
Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.
Measured: 12 months after surgery
Plasma Leptin at 12 Months
Leptin is one of the adipose-derived hormones that causes inhibition of appetite. Elevated leptin levels are associated with obesity, inflammation, metabolic syndrome and cardiovascular disease. Weight loss leads to a decline in leptin concentrations.
Measured: 12 months after surgery
Plasma Glucagon at 12 Months
Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.
Measured: 12 months after surgery
Plasma IGF-1 at 12 Months
Insulin like growth factor 1 (IGF-1) is similar in structure to insulin. It has anabolic effects. Its levels may be related to BMI and level of nutrition.
Measured: 12 months after surgery
AST Level
Measured: 12 months
ALT Level
Measured: 12 months
INR
Measured: 12 months
Albumin Level
Measured: 12 months
GGT Level
Measured: 12 months
ALP Level
Measured: 12 months
LDH Level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startNov 2008
- Primary completionMar 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafał Paluszkiewicz, Prof. MD,PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806506
- Sponsor's protocol ID
- KBN N N403 3882 33
- Status last verified
- Jan 2013
- First submitted
- 31 Jan 2013
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kalinowski P, Paluszkiewicz R, Ziarkiewicz-Wroblewska B, Wroblewski T, Remiszewski P, Grodzicki M, Krawczyk M. Liver Function in Patients With Nonalcoholic Fatty Liver Disease Randomized to Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy: A Secondary Analysis of a Randomized Clinical Trial. Ann Surg. 2017 Nov;266(5):738-745. doi: 10.1097/SLA.0000000000002397.
PubMed 28767558
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity and Underlying Metabolic and Hormonal Abnormalities
- ClinicalTrials.gov ID
- NCT01806506
- Acronym / sponsor ID
- KBN N N403 3882 33
- Keywords
- Bariatric surgery, Gastric bypass, Sleeve gastrectomy, Weight loss, Lipoproteins, Insulin resistance, Incretins, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.
Detailed description
Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is necessary. The former method is the established "gold standard" procedure with good outcomes reported in many studies. However it is much more complex and the learning curve is longer. The latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. It produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. Purely restrictive procedures such as LSG are theoretically less beneficial in this group of patients. In the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Experimental | Procedure: Laparoscopic sleeve gastrectomyThe group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy. |
| Roux-en-Y Gastric Bypass | Experimental | Procedure: Roux-en-Y Gastric BypassThe group of morbidly obese patients assigned to Roux-en-Y gastric bypass. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI≥40 kg/m2
- BMI≥35 kg/m2 with at least one comorbidity associated with obesity
Key exclusion criteria (7 listed)
- BMI > 60 kg/m2
- poorly controlled significant medical or psychiatric disorders
- active alcohol or substance abuse
- active duodenal/gastric ulcer disease
- difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomyLaparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie. | Procedure or surgery | Laparoscopic sleeve gastrectomy |
| Roux-en-Y Gastric BypassRoux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz. | Procedure or surgery | Roux-en-Y Gastric Bypass |
Primary outcome
Excess Weight Loss From Baseline
Time frame: 12 months after surgery
Weight loss measured as a percentage of excess weight lost is one of the most commonly used and accepted outcome measure in clinical trials evaluating bariatric surgery.
26 secondary outcomes
Number of Patients With Complications
Time frame: 12 months after surgery
Comorbidities Prevalence Changes
Time frame: Evaluation at baseline and 1, 6 and 12 months after surgery
Change in Weight From Baseline
Time frame: Evaluation at baseline and 12 months after surgery
Change in BMI From Baseline
Time frame: Baseline and 12 months after surgery
Plasma Total Cholesterol at 12 Months
Time frame: 12 months after surgery
Plasma HDL at 12 Months
Time frame: 12 months after surgery
Plasma LDL at 12 Months
Time frame: 12 months after surgery
Plasma Triglycerides at 12 Months
Time frame: 12 months after surgery
Plasma Glucose at 12 Months
Time frame: 12 months after surgery
Plasma Insulin at 12 Months
Time frame: 12 months after surgery
Plasma C-peptide at 12 Months
Time frame: 12 months after surgery
HOMA Index at 12 Months
Time frame: 12 months after surgery
HbA1c at 12 Months
Time frame: 12 months after surgery
Plasma CRP at 12 Months
Time frame: 12 months after surgery
Plasma Uric Acid at 12 Months
Time frame: 12 months after surgery
Plasma Ghrelin at 12 Months
Time frame: 12 months after surgery
Plasma Leptin at 12 Months
Time frame: 12 months after surgery
Plasma Glucagon at 12 Months
Time frame: 12 months after surgery
Plasma IGF-1 at 12 Months
Time frame: 12 months after surgery
AST Level
Time frame: 12 months
ALT Level
Time frame: 12 months
INR
Time frame: 12 months
Albumin Level
Time frame: 12 months
GGT Level
Time frame: 12 months
ALP Level
Time frame: 12 months
LDH Level
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28767558Kalinowski P, Paluszkiewicz R, Ziarkiewicz-Wroblewska B, Wroblewski T, Remiszewski P, Grodzicki M, Krawczyk M. Liver Function in Patients With Nonalcoholic Fatty Liver Disease Randomized to Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy: A Secondary Analysis of a Randomized Clinical Trial. Ann Surg. 2017 Nov;266(5):738-745. doi: 10.1097/SLA.0000000000002397.
- Medical University of Warsaw web siteLink provided by the sponsor.
- Chair and Department of General Transplant and Liver Surgery, Medical University of WarsawLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rafał Paluszkiewicz, Prof. MD,PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy and Roux-en-Y Gastric Bypass in people with Morbid Obesity and Metabolic Syndrome X, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 7 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 20 Feb 2019. 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 Poland. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Excess Weight Loss From Baseline (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806506, which also lists 1 linked publication.
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 20 Feb 2019.