NCT03796325

Brief Summary

Obesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

December 29, 2018

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight loss 3 years after laparoscopic sleeve gastrectomy

    Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery

    36 month

Secondary Outcomes (1)

  • Depression state changes after Sleeve gastrectomy

    36 month

Study Arms (2)

Depression

patients characterize with morbid obesity or obesity type 2 with co-morbidities and depression

No-depression

patients characterize with morbid obesity or obesity type 2 with co-morbidities without depression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years and older with BMI at less 40 or 35-40 with co-morbidities

You may not qualify if:

  • Any surgical complication Previous gastrointestinal surgery schizofrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta MC

Tel Aviv, Israel

Location

Related Publications (1)

  • Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018.

    PMID: 30524743BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidDepression

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of General Surgery

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 8, 2019

Study Start

January 1, 2013

Primary Completion

December 31, 2017

Study Completion

December 22, 2018

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations