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

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT04663919
Collaborator
(none)
55
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery-RYGB
  • Behavioral: Dietary intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Apr 7, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anorexia Nervosa

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

Behavioral: Dietary intervention
High-calorie medical nutrition program to ensure weight gain

Active Comparator: Morbidly Obese

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)

Procedure: Bariatric surgery-RYGB
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).

No Intervention: Healthy Volunteer

Volunteers with normal BMI and without any additional chronic disease

Outcome Measures

Primary Outcome Measures

  1. Plasma Leptin levels changes: [3 months on average]

    Change in baseline Leptin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.

  2. Plasma Apelin levels changes [3 months on average]

    Change in baseline Apelin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.

  3. Plasma Omentin levels changes [3 months on average]

    Change in baseline Omentin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.

  4. Plasma Adiponectin levels changes [3 months on average]

    Change in baseline Adiponectin levels at when decreasing by 10 percent or increasing by 10 percent from initial weight. Measured by plasma samples.

  5. Plasma IL-6 levels changes [3 months on average]

    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

  1. Weight change [3 months on average]

    Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.

  2. Fat mass change [3 months on average]

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

  3. Fat free mass changes [3 months on average]

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

Other Outcome Measures

  1. Serum glucose change [3 months on average]

    Change in baseline glucose (mg/dl) at when decreasing by 10 percent or increasing by 10 percent from initial weight.

  2. Serum insulin change [3 months on average]

    Change in baseline insulin (µU/mL) at when decreasing by 10 percent or increasing by 10 percent from initial weight.

  3. Serum CRP change [3 months on average]

    Change in baseline CRP at when decreasing by 10 percent or increasing by 10 percent from initial weight.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fulya Turker, MD, PhD; Academivian; Principle Investigator, Istanbul University
ClinicalTrials.gov Identifier:
NCT04663919
Other Study ID Numbers:
  • 246164
First Posted:
Dec 11, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fulya Turker, MD, PhD; Academivian; Principle Investigator, Istanbul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2020