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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Bariatric Surgery; Weight Change, Body
• Intervention / Treatment: Behavioral: Dietary intervention; Procedure: Bariatric surgery-RYGB

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months on average
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.	3 months on average
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.	3 months on average
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.	3 months on average
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.	3 months on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.	3 months on average
Fat mass change	Change in baseline fat mass (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.	3 months on average
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.	3 months on average

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum glucose change	Change in baseline glucose (mg/dl) at when decreasing by 10 percent or increasing by 10 percent from initial weight.	3 months on average
Serum insulin change	Change in baseline insulin (µU/mL) at when decreasing by 10 percent or increasing by 10 percent from initial weight.	3 months on average
Serum CRP change	Change in baseline CRP at when decreasing by 10 percent or increasing by 10 percent from initial weight.	3 months on average

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): April 7, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: leptin; omentin; Bariatric Surgery; IL-6; Anorexia Nervosa; adipocytokines; fat mass; adiponectin; apelin
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Overnutrition; Nutrition Disorders; Overweight; Obesity; Anorexia; Anorexia Nervosa; Body Weight; Obesity, Morbid; Body Weight Changes
• Other Study ID Numbers: 246164

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No