Durability of Weight Loss After Bariatric Surgery | NCT04650373

Studies
Durability of Weight Loss After Bariatric Surgery

NCT04650373

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Dec 2, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Obesity

Interventions

Bariateric surgery

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2014Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Jan 25, 2020Actual

First Submitted Date

Nov 24, 2020

First Submission Date that Met QC Criteria

Dec 1, 2020

First Posted Date

Dec 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2020

Last Update Posted Date

Dec 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdulkarim Hasan, Pathologist and Laboratory Director, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study is a retrospective cohort study. Patients older than 18 years of age and underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

Detailed Description

This is a retrospective cohort study. The sample size of our study includes one hundred case older than 18 years of age and underwent RYGB surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. Data was collected taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. Outcomes: The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. The secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical management		Underwent bariatric surgery	Procedure: Bariateric surgery
Non-surgical management		Patients treated medically

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariateric surgery	Procedure	Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019	Surgical management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight-change percentage at follow-up	Weight loss or gain in kilogram after surgery is evaluated.	1 year
Clinical Events, Diabetes Miletus	The secondary effects of the clinical events after surgery including incidence of diabetes disease (DM) is measured using the blood glucose level. Fasting blood glucose level more than 7.1 mmol/L is considered posutive for DM	1 year
Clinical Events, Hypertension	Arterial blood pressure is followed up regularly, three consequences increase of the blood pressure more than 140 mm Hg systolic and 90 mm Hg diastolic, is positive for hypertension	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients equal or over 18 years old
BMI more than 40
Complete follow up

Exclusion Criteria:

No complete follow up
Age less than 18 or more than 80

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients in Al-Azhar University hospital for overweight or obesity problems

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamad Baheeg	Al-Azhar University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abdulkarim Hasan		Cairo		11884	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided