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.: PACTR201803003164260 Date of Approval: 06/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Obesity and diabetes mellutis
Official scientific title Study of the Effect of Laparoscopic Mini Gastric Bypass Versus Sleeve Gastrectomy On Obese Type 2 Diabetic Patients
Brief summary describing the background and objectives of the trial Introduction: Given the role of obesity in the etiology of Type 2 diabetes, recent guidelines on diabetes treatment provide that weight loss should be the most logical and cost-effective means of controlling Type 2 diabetes. Bariatric procedures aim to reduce weight and maintain weight loss through altering energy balance, primarily by reducing food intake and modifying the physiological changes that drive weight regain.Objectives:Tocompare laparoscopic mini-gastricbypass and laparoscopic sleeve gastrectomy regarding the efficacy of control of type 2 D.M in obese patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Obesity ,diabetes mellitus,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2014
Actual trial start date 14/12/2014
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 04/12/2016
Anticipated target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using closed envelopment method Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laparoscopic sleeve gastrectomy Longtudinal resection of 85% of stomach 30 Active-Treatment of Control Group
Experimental Group Laparoscopic minigastric bypass Separating small pouch of stomach at lesser curvature and connecting it to intestine bypassing proximal 2 metre of bowel 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- having Type 2 DM -above age of 18 years -body mass index (BMI) ¿30 kg/m2 -willing to sign an informed consent - comply with the evaluation and treatment schedules. -patients with endocrine abnormalities: e.g. hypothyroidism,Cushing syndrome and --those who have undergone previous bariatric operations, major upper abdominal surgery -those with Type1DM -younger than 18 years old - Pregnant or lactating females -Patient with contraindications for insufflation as those with sever cardiovascular or sever restrictive respiratory diseases -patients with significant abdominal ventral hernia -patient with major psychiatric illness 18 Year(s) 60 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 29/03/2015 Research ethics committee of department of general surgery ain shams university
Ethics Committee Address
Street address City Postal code Country
Ramsees street, Abbasia , cairo Cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare laparoscopic mini-gastric bypass and laparoscopic sleeve gastrectomy regarding the efficacy of control of type 2 D.M in obese patients. Measurement of HbA1c and FBS, at 3, 6 and 12 months and follow up of changes in dosage or discontinuation of anti-diabetic medications.
Secondary Outcome Predictors of remission of type 2 diabetes in obese patients after bariatric surgery -age -gender -preoperative c-peptide level ( more or less than 3ng/ml) -preoperative diabetes status(controlled or not) -preoperative antidiabetes medication ( oral hypoglycemic or insuline) - BMI loss after 3,6,12 months - preoperative diabetes duration ( more or less than 5 years) -Family history of diabetes (positive or negative) - type of obesity ( central or peripheral)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eldemerdash hospitals Cairo - Egypt Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
General surgery department, ain shams university Ramsees street, Abbasia Cairo 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor General surgery department, ain shams university Ramsees street, Abbasia Cairo 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hossam sobhy abdelraheem Sleem elwal street Cairo 002 Egypt
Mahmood saad arafat Hadaiac El qoba Cairo 002 Egypt
Ahmed Elnabeel mortada Naser city Cairo 002 Egypt
Haitham mostafa elmaleh Naser city Cairo 002 Egypt
Ahmed Mohamed BahaaEldin Masr elgededa Cairo 002 Egypt
Alyaa ahmed elsherbeny Naser city Cairo 002 Egypt
Maram M.M.Aboromia Masr elgededa Cairo 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmmod Farahat mahmoud.sd.farahat@gmail.com 01111158628 Hadaic elqoba
City Postal code Country Position/Affiliation
Cairo 002 Egypt Professor of general surgery -ain shams university
Role Name Email Phone Street address
Public Enquiries Hossam Rady Hosam_l_n@yahoo.com 01110540267 Sleem Elawal street - ain shams
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Haitham Elmaleh hmalmaleh@hotmail.com 01006383143 Nasr city
City Postal code Country Position/Affiliation
Cairo 002 Egypt Assistant Professor of general surgery -ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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