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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04663919
Other study ID # 246164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date January 1, 2015

Study information

Verified date December 2020
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 1, 2015
Est. primary completion date April 7, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 60 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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