Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407873710427 Date of Approval: 22/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Impact of Sleeve Gastrectomy and One Anastomosis Gastric Bypass on Glycemic Control and Abdominal Adiposity: A Randomized Controlled Study
Official scientific title Comparative Impact of Sleeve Gastrectomy and One Anastomosis Gastric Bypass on Glycemic Control and Abdominal Adiposity: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial It has been presumed that both abdominal subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) depots are considered a crucial part of the endocrine system, which is implicated in the multifaceted interplay among obesity, metabolic complications, and systemic inflammation. Both fat depots, along with intrahepatic fat, have been described to be involved in metabolic complications through the secretion of bioactive cytokines, leading to resistance to insulin and subsequent type 2 DM. We aim to study the effect of sleeve gastrectomy and one anastomosis gastric bypass in the loss of visceral fat and correlate the effect of fat loss on the control of diabetes mellitus in both surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2022
Actual trial start date 21/09/2022
Anticipated date of last follow up 06/02/2024
Actual Last follow-up date 22/02/2024
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group OAGB The operation will take about one to two hours One anastomosis gastric bypass includes creation of small pocket of stomach with anastomosis to part of small bowel 30
Control Group SG 1-1.6 hourd sleeve gastrectomy was done for all patients 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
above 14 years old. 2. Patients were indicated for bariatric surgery according to IFSO and ASMBS criteria. 3. Patients were previously known diabetic fitting one of American Diabetes Association criteria for the diagnosis of diabetes on medical treatment or accidently discovered to be diabetic on presentation with high HBA1C ≥ 6.5. 4. Patients did not have any contraindications for both laparoscopic OAGB and LSG. 5. Patients were generally fit for anesthesia and surgery. pregnant after bariatric procedures in the follow-up period. 2. Patients underwent previous bariatric surgery. 3. Patients were non-compliant. 4. Patients were unwilling to be part of the RCT. 5. Patients developed illnesses affecting weight loss significantly as malignancy. 6. Patients lost follow-up. 7. Patients were not fit for either OAGB or LSG Adult: 19 Year-44 Year 14 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/08/2022 Cairo University faculty of medicine research ethics Committee
Ethics Committee Address
Street address City Postal code Country
El Saray Street Manial Cairo 11956 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glycemic control after the two procedures and its association with the abdominal adiposity measures 12 months post intervention
Secondary Outcome weight loss and other metabolic improvements in the two groups. 12-month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasralainy teaching hospital El Saray Street Manial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasralainy teaching hospital El Saray Street Manial Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasralainy teaching hospital El Saray Street Manial Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elmekawy Dr.mohammed.s.h.2013@gmail.com +201274911376 El Saray Street Manial
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer at faculty of medicine Cairo University
Role Name Email Phone Street address
Principal Investigator Hytham Mohey dochytham@gmail.com +201008876772 Alobour
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at faculty of medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Sami Saied smufeed@kasralainy.edu.eg +201222126260 El Saray Street Manial
City Postal code Country Position/Affiliation
Cairo Egypt Professor at faculty of medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Statistical Analysis Plan,Study Protocol Beginning 11 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information