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Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic sleeve Gastrectomy
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Laparoscopic sleeve gastrectomy, Obesity, menstrual cycle

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age ranged from 18~45 years old,
  • BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Exclusion Criteria:

  • outside of the 18-45 age range;
  • secondary obesity caused by endocrine disorders;
  • history of more than one bariatric procedure;
  • severe hepatic, renal or heart dysfunction;
  • mental illnesses or intellectual disability.
  • pregnancy or lactation
  • contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PCOS group

    Control group

    Arm Description

    Obese Patients with PCOS underwent LSG

    Sample obese patients without PCOS underwent LSG

    Outcomes

    Primary Outcome Measures

    Menstrual cycles
    the total number of menstrual periods in the last year

    Secondary Outcome Measures

    ZAG
    zinc-alpha2-glycoprotein
    FGF-19
    fibroblast growth factor 19
    FGL-1
    fibrinogen-like protein 1
    BMI
    BMI=weight(kg)/height(m)^2
    Waist/hip Ratio
    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter
    TT
    total testosterone in nmol/L
    FBG
    fasting blood-glucose in mmol/L
    PBG
    postprandial blood-glucose in mmol/L
    FINS
    fasting serum insulin in mU/L
    PINS
    postprandial insulin in mU/L
    ALT
    alanine aminotransferase in U/L
    AST
    aspartate aminotransferase in U/L
    UA
    Uric acid in umol/L
    HOMA-IR
    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5
    HbA1c (%)
    Glycated hemoglobin
    SHBG
    sex hormone-binding globulin in nmol/L
    FT
    free testosterone (nmol/L)
    DHEAS
    Dehydroepiandrosterone Sulfate (ug/dl)
    LDL-C
    low-density lipoprotein cholesterol in mmol/L
    HDL-C
    Hight-density lipoprotein cholesterol in mmol/L
    Fertility
    sexual function, fertility
    LH
    luteinizing hormone in IU/L
    FSH
    follicle-stimulating hormone in IU/l
    E2
    Estradiol in pmol/L
    PRL
    Prolactin in uIU/ml
    CR
    Creatinine in umol/L
    AD
    Androstenedione in ng/ml
    TC
    Total Cholesterol (mmol/L)
    TG
    Triglyceride (mmol/L)

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    September 29, 2022
    Sponsor
    Shanghai 10th People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05536583
    Brief Title
    Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS
    Official Title
    Shanghai Tenth People's Hospital，School of Medicine, Tongji University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    December 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai 10th People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.
    Detailed Description
    This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled. All PCOS patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis were measured baseline and postoperative.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    Polycystic ovary syndrome, Laparoscopic sleeve gastrectomy, Obesity, menstrual cycle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCOS group
    Arm Type
    Experimental
    Arm Description
    Obese Patients with PCOS underwent LSG
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Sample obese patients without PCOS underwent LSG
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic sleeve Gastrectomy
    Intervention Description
    Laparoscopic sleeve Gastrectomy
    Primary Outcome Measure Information:
    Title
    Menstrual cycles
    Description
    the total number of menstrual periods in the last year
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    ZAG
    Description
    zinc-alpha2-glycoprotein
    Time Frame
    3 years
    Title
    FGF-19
    Description
    fibroblast growth factor 19
    Time Frame
    3 years
    Title
    FGL-1
    Description
    fibrinogen-like protein 1
    Time Frame
    3 years
    Title
    BMI
    Description
    BMI=weight(kg)/height(m)^2
    Time Frame
    3 years
    Title
    Waist/hip Ratio
    Description
    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter
    Time Frame
    3 years
    Title
    TT
    Description
    total testosterone in nmol/L
    Time Frame
    3 years
    Title
    FBG
    Description
    fasting blood-glucose in mmol/L
    Time Frame
    3 years
    Title
    PBG
    Description
    postprandial blood-glucose in mmol/L
    Time Frame
    3 years
    Title
    FINS
    Description
    fasting serum insulin in mU/L
    Time Frame
    3 years
    Title
    PINS
    Description
    postprandial insulin in mU/L
    Time Frame
    3 years
    Title
    ALT
    Description
    alanine aminotransferase in U/L
    Time Frame
    3 years
    Title
    AST
    Description
    aspartate aminotransferase in U/L
    Time Frame
    3 years
    Title
    UA
    Description
    Uric acid in umol/L
    Time Frame
    3 years
    Title
    HOMA-IR
    Description
    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5
    Time Frame
    3 years
    Title
    HbA1c (%)
    Description
    Glycated hemoglobin
    Time Frame
    3 years
    Title
    SHBG
    Description
    sex hormone-binding globulin in nmol/L
    Time Frame
    3 years
    Title
    FT
    Description
    free testosterone (nmol/L)
    Time Frame
    3 years
    Title
    DHEAS
    Description
    Dehydroepiandrosterone Sulfate (ug/dl)
    Time Frame
    3 years
    Title
    LDL-C
    Description
    low-density lipoprotein cholesterol in mmol/L
    Time Frame
    3 years
    Title
    HDL-C
    Description
    Hight-density lipoprotein cholesterol in mmol/L
    Time Frame
    3 years
    Title
    Fertility
    Description
    sexual function, fertility
    Time Frame
    3 years
    Title
    LH
    Description
    luteinizing hormone in IU/L
    Time Frame
    3 years
    Title
    FSH
    Description
    follicle-stimulating hormone in IU/l
    Time Frame
    3 years
    Title
    E2
    Description
    Estradiol in pmol/L
    Time Frame
    3 years
    Title
    PRL
    Description
    Prolactin in uIU/ml
    Time Frame
    3 years
    Title
    CR
    Description
    Creatinine in umol/L
    Time Frame
    3 years
    Title
    AD
    Description
    Androstenedione in ng/ml
    Time Frame
    3 years
    Title
    TC
    Description
    Total Cholesterol (mmol/L)
    Time Frame
    3 years
    Title
    TG
    Description
    Triglyceride (mmol/L)
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ranged from 18~45 years old, BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. Exclusion Criteria: outside of the 18-45 age range; secondary obesity caused by endocrine disorders; history of more than one bariatric procedure; severe hepatic, renal or heart dysfunction; mental illnesses or intellectual disability. pregnancy or lactation contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,

    12. IPD Sharing Statement

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    Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

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