Morbid ObesityNCT04414072
Local GIT Hormones After Bariatric Maneuvers
A study testing sleeve gastrectomy with loop bipartition in people with Morbid Obesity, run by Minia University at 1 site in Egypt.
Trial summary
Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- sleeve gastrectomy with loop bipartition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All morbid obese patients
- -
Who cannot join
- GIT diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia university
Minya
Minia University, (086) 2366149, minia.edu.org@yahoo.com
About this study
Official title: Effect of Bariatric Surgery
Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides.
Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients.
Read the detailed description
Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients. Age ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist, Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done after two weeks and after 2 months.
- Conditions
- Morbid Obesity
- Being tested
- sleeve gastrectomy with loop bipartition
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy with loop bipartitionProcedure or surgery
Also called minigastric bypass
operations to decrease weight
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy | Active comparator | Not described Receives: Procedure: sleeve gastrectomy with loop bipartition |
| mini gastric bypass | Active comparator | Not described Receives: Procedure: sleeve gastrectomy with loop bipartition |
| sleeve gastrectomy with loop bipartition | Active comparator | Not described Receives: Procedure: sleeve gastrectomy with loop bipartition |
What is being measured
The primary outcome is the main question the study is designed to answer.
hormonal change
GIT hormones (Ghrelin, secretin, PYY, GLP-1)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Minia 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- surgeries
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel Hameed El heny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414072
- Sponsor's protocol ID
- 367177
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04414072
- Acronym / sponsor ID
- 367177
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 4 Jun 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.
Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides.
Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients.
Detailed description
Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients. Age ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist, Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done after two weeks and after 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- surgeries
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy | Active comparator | Procedure: sleeve gastrectomy with loop bipartition |
| mini gastric bypass | Active comparator | Procedure: sleeve gastrectomy with loop bipartition |
| sleeve gastrectomy with loop bipartition | Active comparator | Procedure: sleeve gastrectomy with loop bipartition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All morbid obese patients
- -
Key exclusion criteria (1 listed)
- GIT diseases
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 |
|---|---|---|
| sleeve gastrectomy with loop bipartitionAlso: minigastric bypassoperations to decrease weight | Procedure or surgery | laparoscopic sleeve gastrectomy, mini gastric bypass, sleeve gastrectomy with loop bipartition |
Primary outcome
hormonal change
Time frame: one year
GIT hormones (Ghrelin, secretin, PYY, GLP-1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve gastrectomy with loop bipartition in people with Morbid Obesity, run by Minia 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 2 inclusion and 1 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 4 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hormonal change (time frame: one year). 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 4 Jun 2020.