NCT04663919

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 5, 2020

Last Update Submit

December 14, 2020

Conditions

Anorexia NervosaBariatric SurgeryWeight Change, Body

Keywords

adipocytokinesleptinadiponectinomentinapelinIL-6Anorexia NervosaBariatric Surgeryfat mass

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Weight change

    3 months on average

  • Fat mass change

    3 months on average

  • Fat free mass changes

    3 months on average

Other Outcomes (3)

  • Serum glucose change

    3 months on average

  • Serum insulin change

    3 months on average

  • Serum CRP change

    3 months on average

Study Arms (3)

Anorexia Nervosa

ACTIVE COMPARATOR

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

Morbidly Obese

ACTIVE COMPARATOR

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

Healthy Volunteer

NO INTERVENTION

Volunteers with normal BMI and without any additional chronic disease

Interventions

Bariatric surgery-RYGBPROCEDURE

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).

Morbidly Obese
Dietary interventionBEHAVIORAL

High-calorie medical nutrition program to ensure weight gain

Anorexia Nervosa

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anorexia NervosaBody Weight Changes

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD; Academivian; Principle Investigator

Study Record Dates

First Submitted

December 5, 2020

First Posted

December 11, 2020

Study Start

January 1, 2014

Primary Completion

April 7, 2014

Study Completion

January 1, 2015

Last Updated

December 17, 2020

Record last verified: 2020-12