Diabetes Mellitus, Dyslipidemia, Hypertension, Metabolic Syndrome X, Morbid Obesity
Conditions
Keywords
Bariatric surgery, Gastric bypass, Sleeve gastrectomy, Weight loss, Lipoproteins, Insulin resistance, Incretins, Quality of life
Brief 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. 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.
Interventions
PROCEDURELaparoscopic sleeve gastrectomy
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.
PROCEDURERoux-en-Y Gastric Bypass
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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* BMI≥40 kg/m2 * BMI≥35 kg/m2 with at least one comorbidity associated with obesity
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excess Weight Loss From Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Complications | 12 months after surgery | 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 |
| Comorbidities Prevalence Changes | Evaluation at baseline and 1, 6 and 12 months after surgery | 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. |
| Change in Weight From Baseline | Evaluation at baseline and 12 months after surgery | 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. |
| Change in BMI From Baseline | Baseline and 12 months after surgery | Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline. |
| Plasma Total Cholesterol at 12 Months | 12 months after surgery | Fasting plasma total cholesterol concentration in patients 12 months after surgery. |
| Plasma HDL at 12 Months | 12 months after surgery | Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery. |
| Plasma LDL at 12 Months | 12 months after surgery | Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery. |
| Plasma Triglycerides at 12 Months | 12 months after surgery | Fasting plasma triglycerides concentration in patients 12 months after surgery. |
| Plasma Glucose at 12 Months | 12 months after surgery | Fasting plasma glucose concentration in patients 12 months after surgery. |
| Plasma Insulin at 12 Months | 12 months after surgery | Fasting plasma insulin concentration in patients 12 months after surgery. |
| Plasma C-peptide at 12 Months | 12 months after surgery | Fasting plasma C-peptide concentration in patients 12 months after surgery. |
| HOMA Index at 12 Months | 12 months after surgery | 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 |
| HbA1c at 12 Months | 12 months after surgery | The proportion of glycosylated hemoglobin (HbA1c) \[%\] is measured to assesses the average plasma glucose concentration and regulation. |
| ALP Level | 12 months | — |
| LDH Level | 12 months | — |
| Plasma CRP at 12 Months | 12 months after surgery | C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk. |
| Plasma Uric Acid at 12 Months | 12 months after surgery | Hyperuricemia is associated with metabolic syndrome and obesity. |
| Plasma Ghrelin at 12 Months | 12 months after surgery | Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures. |
| Plasma Leptin at 12 Months | 12 months after surgery | 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. |
| Plasma Glucagon at 12 Months | 12 months after surgery | Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose. |
| Plasma IGF-1 at 12 Months | 12 months after surgery | 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. |
| AST Level | 12 months | — |
| ALT Level | 12 months | — |
| INR | 12 months | — |
| Albumin Level | 12 months | — |
| GGT Level | 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire Score | 12 months after surgery | Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire) |
| Pulmonary Function Changes at 12 Months | Baseline and 12 months from surgery | Spirometry and plethysmography results are used to assess pulmonary function before and after surgery. |
Countries
Poland
Participant flow
Recruitment details
The patients were recruited from the population of patients referred for bariatric consultation to the outpatient clinic of the Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Poland. The recruitment started in November 2008 and finished when the planned number of patients had been recruited for the study.
Pre-assignment details
Eighty six patients meeting the general criteria for bariatric surgery were evaluated for eligibility for the study. Six patients did not meet eligibility criteria (age \> 60 years in 5 patients, suspicion of malignancy in 1 patient) and 8 patients decided not to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Sleeve Gastrectomy The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.
Laparoscopic sleeve gastrectomy: 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. | 36 |
| Roux-en-Y Gastric Bypass The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.
Roux-en-Y Gastric Bypass: 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. | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Roux-en-Y Gastric Bypass | Laparoscopic Sleeve Gastrectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Continuous | 43.9 years STANDARD_DEVIATION 10.8 | 44.9 years STANDARD_DEVIATION 10.6 | 44.4 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Poland | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 36 | 6 / 36 |
| serious Total, serious adverse events | 3 / 36 | 0 / 36 |
Outcome results
Primary
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.
Time frame: 12 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Excess Weight Loss From Baseline | 67.8 percentage of EWL | Standard Deviation 19.3 |
| Roux-en-Y Gastric Bypass | Excess Weight Loss From Baseline | 64.2 percentage of EWL | Standard Deviation 18.5 |
Secondary
Albumin Level
Time frame: 12 months
Secondary
ALP Level
Time frame: 12 months
Secondary
ALT Level
Time frame: 12 months
Secondary
AST Level
Time frame: 12 months
Secondary
Change in BMI From Baseline
Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.
Time frame: Baseline and 12 months after surgery
Secondary
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.
Time frame: Evaluation at baseline and 12 months after surgery
Secondary
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.
Time frame: Evaluation at baseline and 1, 6 and 12 months after surgery
Secondary
GGT Level
Time frame: 12 months
Secondary
HbA1c at 12 Months
The proportion of glycosylated hemoglobin (HbA1c) \[%\] is measured to assesses the average plasma glucose concentration and regulation.
Time frame: 12 months after surgery
Secondary
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
Time frame: 12 months after surgery
Secondary
INR
Time frame: 12 months
Secondary
LDH Level
Time frame: 12 months
Secondary
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
Time frame: 12 months after surgery
Secondary
Plasma C-peptide at 12 Months
Fasting plasma C-peptide concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
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.
Time frame: 12 months after surgery
Secondary
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.
Time frame: 12 months after surgery
Secondary
Plasma Glucagon at 12 Months
Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.
Time frame: 12 months after surgery
Secondary
Plasma Glucose at 12 Months
Fasting plasma glucose concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
Plasma HDL at 12 Months
Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
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.
Time frame: 12 months after surgery
Secondary
Plasma Insulin at 12 Months
Fasting plasma insulin concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
Plasma LDL at 12 Months
Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
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.
Time frame: 12 months after surgery
Secondary
Plasma Total Cholesterol at 12 Months
Fasting plasma total cholesterol concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
Plasma Triglycerides at 12 Months
Fasting plasma triglycerides concentration in patients 12 months after surgery.
Time frame: 12 months after surgery
Secondary
Plasma Uric Acid at 12 Months
Hyperuricemia is associated with metabolic syndrome and obesity.
Time frame: 12 months after surgery
Other Pre-specified
Pulmonary Function Changes at 12 Months
Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.
Time frame: Baseline and 12 months from surgery
Other Pre-specified
Quality of Life Questionnaire Score
Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)
Time frame: 12 months after surgery