Anorexia NervosaNCT04663919
Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
A study testing Bariatric surgery-RYGB and Dietary intervention in people with Anorexia Nervosa and Bariatric Surgery, run by Istanbul University.
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… Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bariatric Surgery, Weight Change, Body
- What is being tested?
- Bariatric surgery-RYGB and Dietary intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- <13 and> 60 years old
- to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa, Bariatric Surgery, Weight Change, Body
- Being tested
- Bariatric surgery-RYGB, Dietary intervention
- Keywords
- adipocytokines, leptin, adiponectin, omentin, apelin, IL-6, Anorexia Nervosa, Bariatric Surgery, fat mass
- Medical subject headings
- Anorexia Nervosa, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery-RYGBProcedure or surgery
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 interventionBehavioural
High-calorie medical nutrition program to ensure weight gain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Procedure: Bariatric surgery-RYGB |
| Healthy Volunteer | No intervention | Volunteers with normal BMI and without any additional chronic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months on average
Secondary outcomes (3)
Weight change
Change in baseline weight (kg) at when decreasing by 10 percent or increasing by 10 percent from initial weight.
Measured: 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.
Measured: 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.
Measured: 3 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2014
- Primary completion7 Apr 2014
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Turker, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663919
- Sponsor's protocol ID
- 246164
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity
- ClinicalTrials.gov ID
- NCT04663919
- Acronym / sponsor ID
- 246164
- Conditions
- Anorexia Nervosa, Bariatric Surgery, Weight Change, Body
- Keywords
- adipocytokines, leptin, adiponectin, omentin, apelin, IL-6, Anorexia Nervosa, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 7 Apr 2014 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | Active comparator | Behavioral: Dietary interventionPatients 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 |
| Morbidly Obese | Active comparator | Procedure: Bariatric surgery-RYGBPatients 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) |
| Healthy Volunteer | No intervention | –Volunteers with normal BMI and without any additional chronic disease |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- for Anorexia Nervosa group:
- for Morbidly Obese group:
- for Healthy Volunteers:
Key exclusion criteria (2 listed)
- <13 and> 60 years old
- to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgery-RYGBAfter 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). | Procedure or surgery | Morbidly Obese |
| Dietary interventionHigh-calorie medical nutrition program to ensure weight gain | Behavioural | Anorexia Nervosa |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Weight change
Time frame: 3 months on average
Fat mass change
Time frame: 3 months on average
Fat free mass changes
Time frame: 3 months on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery-RYGB and Dietary intervention in people with Anorexia Nervosa and Bariatric Surgery, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Leptin levels changes: (time frame: 3 months on average). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.