search
Back to results

Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity

Primary Purpose

Anorexia Nervosa, Bariatric Surgery, Weight Change, Body

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric surgery-RYGB
Dietary intervention
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring adipocytokines, leptin, adiponectin, omentin, apelin, IL-6, Anorexia Nervosa, Bariatric Surgery, fat mass

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • for Anorexia Nervosa group:

    • Have been diagnosed with anorexia nervosa
    • BMI <18 kg/m2
    • Good general health
    • Volunteering to participate in the study
  • for Morbidly Obese group:

    • Who was diagnosed with morbid obesity and planned to undergo RYGB operation
    • BMI> 40 kg/m2
    • Volunteering to participate in the study
  • for Healthy Volunteers:

    • Good general health
    • BMI >20 and <30 kg/m2
    • Volunteering to participate in the study

Exclusion Criteria:

  • <13 and> 60 years old
  • to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Anorexia Nervosa

    Morbidly Obese

    Healthy Volunteer

    Arm Description

    Patients diagnosed with Anorexia Nervosa, having a BMI of <18, being followed up and treated in the Psychiatry Eating Disorders Polyclinic and endocrinology outpatient clinics, and who have approximately 10% weight gain during the treatment process

    Patients with a BMI> 40 diagnosed with Morbid Obesity and who lost approximately 10% of their weight by performing obesity surgery (gastric bypass or sleeve gastrectomy)

    Volunteers with normal BMI and without any additional chronic disease

    Outcomes

    Primary Outcome Measures

    Plasma Leptin levels changes:
    Change in baseline Leptin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Plasma Apelin levels changes
    Change in baseline Apelin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Plasma Omentin levels changes
    Change in baseline Omentin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Plasma Adiponectin levels changes
    Change in baseline Adiponectin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Plasma IL-6 levels changes
    Change in baseline IL-6 levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.

    Secondary Outcome Measures

    Weight change
    Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Fat mass change
    Change in baseline fat mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Fat free mass changes
    Change in baseline fat free mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.

    Full Information

    First Posted
    December 5, 2020
    Last Updated
    December 14, 2020
    Sponsor
    Istanbul University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04663919
    Brief Title
    Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
    Official Title
    Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    April 7, 2014 (Actual)
    Study Completion Date
    January 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

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

    5. Study Description

    Brief Summary
    In this study, when patients diagnosed with AN started treatment and their weight increased by 10%; On the other hand, it was aimed to compare the changes in serum adipokine levels observed in morbidly obese patients before bariatric surgery and when they lost 10% of their post-op weight with both anthropometric measurements, biochemical parameters, and values of healthy volunteers.
    Detailed Description
    The most characteristic feature of obesity is the increase in adipose tissue. On the contrary, in anorexia nervosa, there is a decrease in adipose tissue enough to impair neuroendocrine functions. Adipose tissue is formed by loosely binding lipid-filled cells called adipocytes and is now considered an important part of energy metabolism. Adipokines it secretes play a role in many physiological processes of the body such as nutrition, appetite, energy balance, insulin, and glucose metabolism, lipid metabolism, regulation of blood pressure, vascular remodeling, coagulation, and inflammation. Therefore, changes in the amount of body fat in these two patient groups, which are at the two ends of the spectrum, affect both the biochemical parameters and physiological functions of the patients in different ways. It is expected that both adipokine levels and biochemical parameters will approach the values of healthy subjects with a decrease in adipose tissue of clinically morbidly obese patients and an increase in adipose tissue of patients with AN. However, in some studies comparing the parameters of patients with constitutionally weak patients and patients with AN, results contrary to expectations were obtained. In this study, we compared the extent to which weight changes changed adipokines and correlated with biochemical parameters based on healthy and normal-weight volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia Nervosa, Bariatric Surgery, Weight Change, Body
    Keywords
    adipocytokines, leptin, adiponectin, omentin, apelin, IL-6, Anorexia Nervosa, Bariatric Surgery, fat mass

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anorexia Nervosa
    Arm Type
    Active Comparator
    Arm Description
    Patients diagnosed with Anorexia Nervosa, having a BMI of <18, being followed up and treated in the Psychiatry Eating Disorders Polyclinic and endocrinology outpatient clinics, and who have approximately 10% weight gain during the treatment process
    Arm Title
    Morbidly Obese
    Arm Type
    Active Comparator
    Arm Description
    Patients with a BMI> 40 diagnosed with Morbid Obesity and who lost approximately 10% of their weight by performing obesity surgery (gastric bypass or sleeve gastrectomy)
    Arm Title
    Healthy Volunteer
    Arm Type
    No Intervention
    Arm Description
    Volunteers with normal BMI and without any additional chronic disease
    Intervention Type
    Procedure
    Intervention Name(s)
    Bariatric surgery-RYGB
    Intervention Description
    After the creation of a 15-25-cc gastric pouch from the upper stomach, transection of proximal jejunum 70 cm from Treitz ligament also called "alimentary tract" and anastomosis of the distal end of jejunum to the gastric pouch, and thereafter, anastomosis of the proximal end of transected jejunum to the distal part of the jejunum at 150 cm below the site of transection (jejunoileal anastomosis).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dietary intervention
    Intervention Description
    High-calorie medical nutrition program to ensure weight gain
    Primary Outcome Measure Information:
    Title
    Plasma Leptin levels changes:
    Description
    Change in baseline Leptin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Time Frame
    3 months on average
    Title
    Plasma Apelin levels changes
    Description
    Change in baseline Apelin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Time Frame
    3 months on average
    Title
    Plasma Omentin levels changes
    Description
    Change in baseline Omentin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Time Frame
    3 months on average
    Title
    Plasma Adiponectin levels changes
    Description
    Change in baseline Adiponectin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Time Frame
    3 months on average
    Title
    Plasma IL-6 levels changes
    Description
    Change in baseline IL-6 levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.
    Time Frame
    3 months on average
    Secondary Outcome Measure Information:
    Title
    Weight change
    Description
    Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average
    Title
    Fat mass change
    Description
    Change in baseline fat mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average
    Title
    Fat free mass changes
    Description
    Change in baseline fat free mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average
    Other Pre-specified Outcome Measures:
    Title
    Serum glucose change
    Description
    Change in baseline glucose (mg/dl) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average
    Title
    Serum insulin change
    Description
    Change in baseline insulin (µU/mL) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average
    Title
    Serum CRP change
    Description
    Change in baseline CRP at when decreasing by 10 percent or increasing by 10 percent from initial weight.
    Time Frame
    3 months on average

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: for Anorexia Nervosa group: Have been diagnosed with anorexia nervosa BMI <18 kg/m2 Good general health Volunteering to participate in the study for Morbidly Obese group: Who was diagnosed with morbid obesity and planned to undergo RYGB operation BMI> 40 kg/m2 Volunteering to participate in the study for Healthy Volunteers: Good general health BMI >20 and <30 kg/m2 Volunteering to participate in the study Exclusion Criteria: <13 and> 60 years old to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity

    We'll reach out to this number within 24 hrs