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Completed

NCT Number: NCT04663919

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bariatric surgery-RYGB

Procedure

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).

Dietary intervention

Behavioral

High-calorie medical nutrition program to ensure weight gain

Primary outcomes

  1. Plasma Leptin levels changes:

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Weight change

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Serum glucose change

    Time frame: 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

    Time frame: 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

    Time frame: 3 months on average

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 11, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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