DepressionNCT06491069
Risk Factors of Depression, Anxiety and Eating Disorder After Bariatric Surgery
An observational study of Depression and Anxiety, run by Sohag University.
Trial summary
the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery. participants will undergo psychometric tests. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety, Eating Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: the group being investigated is patients who had obesity and underwent Bariatric surgery
Who may be able to join
- study sample of humans who had bariatric surgery.
- Subjects with postoperative time of ≥ 3 months
- Male or female aged between 18:60 years.
Who cannot join
- Illiterate patients.
- Patients have dementia or psychosis.
- Age below 18 or above 60 years.
- Patients refused to give written informed consent
Trial locations and contacts
No sites are listed yet.
Taher Abdel Raheem Sayed, professor contact
About this study
Official title: Depression, Anxiety and Eating Disorder After Bariatric Surgery
the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery.
participants will undergo psychometric tests.
Read the detailed description
the aim of this study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery .
and its correlation to postoperative changes in weight .
All data from the subjects will be obtained through direct interviews of postoperative patients
All subjects will be submitted to :
- Obtaining detailed history of
Age , sex , socioeconomic level , work , educational level , marital status , functionality of the patient , special habits (smoking index , alchohol and substance abuse , feeding habits , exercise ).
Evaluating the family history of obesity , psychiatric disorder , Bariatric surgery
Searching for early and late complications of Bariatric surgery : Dumping syndrome , malnutrition , vomiting , hernias , redundant ght loss (by wieght skin , skin infection , vomiting .
Determining the type of surgery. degree of obesity of postoperative patients
evaluated by body mass index
Medical comorbidities Hypertension , diabetes , chronic kidney disease , chronic liver disease , ischemic heart disease , obstructive sleep apnea , gastric reflux , dermatological disorders
Psychometric evaluation
Hamilton Anxiety Rating Scale
Hamilton Depression Rating Scale
Eating disorder evaluation. Eating Attitudes Test-26
- Conditions
- Depression, Anxiety, Eating Disorders, Bariatric Surgery
- Medical subject headings
- Depression, Anxiety Disorders, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
risk factors of depression , anxiety and rating disorder after bariatric surgery
identification of risk factors that lead to occurrence of depression and anxiety and eating disorders in patients who had bariatric surgeris
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sayed Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491069
- Sponsor's protocol ID
- Soh-Med-24-05-01MS
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still undecided
Publications
Sarwer DB, Allison KC, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams NN, Edwards M, Tewksbury C, Wu J. Psychopathology, disordered eating, and impulsivity as predictors of outcomes of bariatric surgery. Surg Obes Relat Dis. 2019 Apr;15(4):650-655. doi: 10.1016/j.soard.2019.01.029. Epub 2019 Feb 23.
PubMed 30858009Brown RM, Guerrero-Hreins E, Brown WA, le Roux CW, Sumithran P. Potential gut-brain mechanisms behind adverse mental health outcomes of bariatric surgery. Nat Rev Endocrinol. 2021 Sep;17(9):549-559. doi: 10.1038/s41574-021-00520-2. Epub 2021 Jul 14.
PubMed 34262156Ivezaj V, Kessler EE, Lydecker JA, Barnes RD, White MA, Grilo CM. Loss-of-control eating following sleeve gastrectomy surgery. Surg Obes Relat Dis. 2017 Mar;13(3):392-398. doi: 10.1016/j.soard.2016.09.028. Epub 2016 Oct 1.
PubMed 27913121undefined
Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
PubMed 22253363
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression, Anxiety and Eating Disorder After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06491069
- Acronym / sponsor ID
- Soh-Med-24-05-01MS
- Conditions
- Depression, Anxiety, Eating Disorders, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 8 Jul 2024 (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.
the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery.
participants will undergo psychometric tests.
Detailed description
the aim of this study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery .
and its correlation to postoperative changes in weight .
All data from the subjects will be obtained through direct interviews of postoperative patients
All subjects will be submitted to :
- Obtaining detailed history of
Age , sex , socioeconomic level , work , educational level , marital status , functionality of the patient , special habits (smoking index , alchohol and substance abuse , feeding habits , exercise ).
Evaluating the family history of obesity , psychiatric disorder , Bariatric surgery
Searching for early and late complications of Bariatric surgery : Dumping syndrome , malnutrition , vomiting , hernias , redundant ght loss (by wieght skin , skin infection , vomiting .
Determining the type of surgery. degree of obesity of postoperative patients
evaluated by body mass index
Medical comorbidities Hypertension , diabetes , chronic kidney disease , chronic liver disease , ischemic heart disease , obstructive sleep apnea , gastric reflux , dermatological disorders
Psychometric evaluation
Hamilton Anxiety Rating Scale
Hamilton Depression Rating Scale
Eating disorder evaluation. Eating Attitudes Test-26
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the group being investigated is patients who had obesity and underwent Bariatric surgery
Key inclusion criteria (3 listed)
- study sample of humans who had bariatric surgery.
- Subjects with postoperative time of ≥ 3 months
- Male or female aged between 18:60 years.
Key exclusion criteria (4 listed)
- Illiterate patients.
- Patients have dementia or psychosis.
- Age below 18 or above 60 years.
- Patients refused to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk factors of depression , anxiety and rating disorder after bariatric surgery
Time frame: baseline
identification of risk factors that lead to occurrence of depression and anxiety and eating disorders in patients who had bariatric surgeris
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 30858009Sarwer DB, Allison KC, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams NN, Edwards M, Tewksbury C, Wu J. Psychopathology, disordered eating, and impulsivity as predictors of outcomes of bariatric surgery. Surg Obes Relat Dis. 2019 Apr;15(4):650-655. doi: 10.1016/j.soard.2019.01.029. Epub 2019 Feb 23.
- Background: PubMed 34262156Brown RM, Guerrero-Hreins E, Brown WA, le Roux CW, Sumithran P. Potential gut-brain mechanisms behind adverse mental health outcomes of bariatric surgery. Nat Rev Endocrinol. 2021 Sep;17(9):549-559. doi: 10.1038/s41574-021-00520-2. Epub 2021 Jul 14.
- Background: PubMed 27913121Ivezaj V, Kessler EE, Lydecker JA, Barnes RD, White MA, Grilo CM. Loss-of-control eating following sleeve gastrectomy surgery. Surg Obes Relat Dis. 2017 Mar;13(3):392-398. doi: 10.1016/j.soard.2016.09.028. Epub 2016 Oct 1.
- Backgroundundefined
- Background: PubMed 22253363Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
- Individual participant dataSharing planned: Undecided. still undecided
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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.
Taher Abdel Raheem Sayed, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Sohag 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sayed Ali, MBBCh (+0201010255939, ahmed_sayed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk factors of depression , anxiety and rating disorder after bariatric surgery (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491069, which also lists 5 linked publications.
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 8 Jul 2024.