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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
Gao Zhiguang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, bariatric surgery, gut hormones, inflammatory adipokine

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 17, 2016
    Last Updated
    November 10, 2016
    Sponsor
    Gao Zhiguang
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    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

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    Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery

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