ObesityNCT04650373
Durability of Weight Loss After Bariatric Surgery
An observational study of Obesity, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Bariateric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2014to 25 Jan 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Al-Azhar University hospital for overweight or obesity problems
Who may be able to join
- Patients equal or over 18 years old
- BMI more than 40
- Complete follow up
Who cannot join
- No complete follow up
- Age less than 18 or more than 80
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Durability of Weight Loss After Bariatric Surgery; A Retrospective Study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Bariateric surgery
- Keywords
- Bariateric surgery, Durability
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariateric surgeryProcedure or surgery
Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019
| Study group | Role | What they receive |
|---|---|---|
| Surgical management | Underwent bariatric surgery Receives: Procedure: Bariateric surgery | |
| Non-surgical management | Patients treated medically |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight-change percentage at follow-up
Weight loss or gain in kilogram after surgery is evaluated.
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start17 Jan 2014
- Primary completion1 Dec 2019
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
- Investigators
- Mohamad Baheeg, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650373
- Sponsor's protocol ID
- AUH20-011
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Durability of Weight Loss After Bariatric Surgery; A Retrospective Study
- ClinicalTrials.gov ID
- NCT04650373
- Acronym / sponsor ID
- AUH20-011
- Conditions
- Obesity
- Keywords
- Bariateric surgery, Durability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 17 Jan 2014 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 2 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical management | – | Procedure: Bariateric surgeryUnderwent bariatric surgery |
| Non-surgical management | – | –Patients treated medically |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Al-Azhar University hospital for overweight or obesity problems
Key inclusion criteria (3 listed)
- Patients equal or over 18 years old
- BMI more than 40
- Complete follow up
Key exclusion criteria (2 listed)
- No complete follow up
- Age less than 18 or more than 80
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 |
|---|---|---|
| Bariateric surgeryAdult patients underwent RYGB surgical treatment during the period from 2014 to 2019 | Procedure or surgery | Surgical management |
Primary outcome
weight-change percentage at follow-up
Time frame: 1 year
Weight loss or gain in kilogram after surgery is evaluated.
Clinical Events, Diabetes Miletus
Time frame: 1 year
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
Clinical Events, Hypertension
Time frame: 1 year
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
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 2 Dec 2020.
- Individual participant dataSharing planned: 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.
Mohamad Baheeg study chair
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Al-Azhar University at 1 site in Egypt.
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 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
weight-change percentage at follow-up (time frame: 1 year). The study lists 3 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 2 Dec 2020.