Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Primary Purpose
Obesity, Chronic Inflammation, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic Roux-en-Y gastric bypass
laparoscopic sleeve gastrectomy
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring obesity, bariatric surgery, gut hormones, inflammatory adipokine
Eligibility Criteria
Inclusion Criteria:
- According to the standard of obesity Obesity Task Force established in 2001, BMI≥28k / m2 with obesity-related metabolic diseases in patients, or BMI≥35kg / m2 in patients with severe obesity were selected.
- The age of 14-65 years.
- Self-capacity, non-drug dependence, psychological illness.
- Not prompted stomach ulcers, erosions, tumors, polyps, atrophic gastritis and other stomach diseases in the preoperative endoscopy.
- No history of stomach and abdominal surgery.
- Case Source: First Affiliated Hospital of Jinan University, by the same team of doctors performed the surgical procedure.
Exclusion Criteria:
- Whom did not follow the inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Roux-en-Y gastric bypass group
sleeve gastrectomy group
Normal BMI group
Arm Description
The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication
The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication
no intervention
Outcomes
Primary Outcome Measures
The levels of Ghrelin, Peptide YY,Glucagon,Gastric Inhibitory Peptide ,and GLP2 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones
The levels of Insulin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin
The levels of Leptin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin
The levels of GLP1 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1
The levels of adipokines and inflammatory cytokines in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Units of adipokines and inflammatory cytokines include Adiponectin in pg/ml, Interleukin 1βin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-α in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
Secondary Outcome Measures
The gut hormone levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
"surgery"means laparoscopic gastric bypass or laparoscopic sleeve gastrectomy. Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones
The Insulin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin.
The Leptin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin
The GLP1 levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1
The adipokines and inflammatory cytokines levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Effect of laparoscopic gastric bypass or laparoscopic sleeve gastrectomy on preoperative and postoperative adipokines and inflammatory cytokines.Units of them include Adiponectin in pg/ml, Interleukin 1βin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-α in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02963662
Brief Title
Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Official Title
Impact of Gut Hormone and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gao Zhiguang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat to our national life and health which is showing a trend. Bariatric Surgery had been confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2 diabetes, but the two surgical methods and principles are completely different, which mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines and inflammatory cytokines induced chronic inflammation and obesity-related complications (insulin resistance and Type 2 diabetes).It is not clear whether to change these gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the operation, which play a therapeutic effect of obesity-related complications and diabetes. In addition, the investigators are wonder whether gut hormones, adipokines and inflammatory cytokines have some correlation in different severity obese patients,. It is worth to explore that could intestinal hormones, adipokines and inflammatory factors levels guide us to choice the different surgical approach to different severity obese patients. The investigators tried to investigate different surgical methods to alleviate diabetes and other metabolic diseases mechanisms though hormones and inflammatory factors and adipose tissue inflammation level and compare the impact of intestinal hormones and inflammatory adipokines of the two surgical approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Chronic Inflammation, Type 2 Diabetes
Keywords
obesity, bariatric surgery, gut hormones, inflammatory adipokine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roux-en-Y gastric bypass group
Arm Type
Experimental
Arm Description
The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication
Arm Title
sleeve gastrectomy group
Arm Type
Experimental
Arm Description
The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication
Arm Title
Normal BMI group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Procedure
Intervention Name(s)
laparoscopic Roux-en-Y gastric bypass
Intervention Description
Laparoscopic Roux-en-Y gastric bypass was one of the interventions pre-specified to be administered to participants. The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Intervention Description
Laparoscopic sleeve gastrectomy was the other intervention pre-specified to be administered to participants. The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication
Primary Outcome Measure Information:
Title
The levels of Ghrelin, Peptide YY,Glucagon,Gastric Inhibitory Peptide ,and GLP2 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Description
Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones
Time Frame
within 4 hours
Title
The levels of Insulin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Description
The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin
Time Frame
within 4 hours
Title
The levels of Leptin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Description
The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin
Time Frame
within 4 hours
Title
The levels of GLP1 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Description
The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1
Time Frame
within 4 hours
Title
The levels of adipokines and inflammatory cytokines in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
Description
Units of adipokines and inflammatory cytokines include Adiponectin in pg/ml, Interleukin 1βin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-α in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
Time Frame
within 4 hours
Secondary Outcome Measure Information:
Title
The gut hormone levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Description
"surgery"means laparoscopic gastric bypass or laparoscopic sleeve gastrectomy. Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones
Time Frame
12 months
Title
The Insulin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Description
The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin.
Time Frame
12 months
Title
The Leptin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Description
The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin
Time Frame
12 months
Title
The GLP1 levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Description
The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1
Time Frame
12 months
Title
The adipokines and inflammatory cytokines levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
Description
Effect of laparoscopic gastric bypass or laparoscopic sleeve gastrectomy on preoperative and postoperative adipokines and inflammatory cytokines.Units of them include Adiponectin in pg/ml, Interleukin 1βin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-α in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
According to the standard of obesity Obesity Task Force established in 2001, BMI≥28k / m2 with obesity-related metabolic diseases in patients, or BMI≥35kg / m2 in patients with severe obesity were selected.
The age of 14-65 years.
Self-capacity, non-drug dependence, psychological illness.
Not prompted stomach ulcers, erosions, tumors, polyps, atrophic gastritis and other stomach diseases in the preoperative endoscopy.
No history of stomach and abdominal surgery.
Case Source: First Affiliated Hospital of Jinan University, by the same team of doctors performed the surgical procedure.
Exclusion Criteria:
Whom did not follow the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingge Yang, MD,PhD
Organizational Affiliation
First Affiliated Hospital of Jinan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30449509
Citation
Yang J, Gao Z, Williams DB, Wang C, Lee S, Zhou X, Qiu P. Effect of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy on fasting gastrointestinal and pancreatic peptide hormones: A prospective nonrandomized trial. Surg Obes Relat Dis. 2018 Oct;14(10):1521-1529. doi: 10.1016/j.soard.2018.06.003. Epub 2018 Jun 14.
Results Reference
derived
Learn more about this trial
Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
We'll reach out to this number within 24 hrs