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.: PACTR201705002192404 Date of Registration: 11/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title diabetes and bariatric suurgery
Official scientific title Role of bariatric surgery in control of blood sugar in obese uncontrolled type 2 diabetic patients
Brief summary describing the background and objectives of the trial Diabesity is the 21th century pandemic. Obesity and type 2 diabetes both present significant public health challenges. The link between the two conditions is important because obesity substantially increases the risk of type 2 diabetes. Type 2 diabetes accounts for about 95% of diabetes cases in the U.S. in 2013. More than 90% of type 2 diabetics are overweight or obese. Typically, it begins in middle or older age, although rates of type 2 diabetes are increasing in young people. The prevalence of both obesity and type 2 diabetes continue to rise, along with associated direct patient care costs and wider costs to society (National Institute of Diabetes and Digestive and Kidney Diseases, 2013). Type 2 diabetes is associated with a ten-year shorter life expectancy. Type 2 diabetes is a major cause of premature mortality and contributes to a range of long-term health conditions including cardiovascular disease and microvascular complications including eye, foot and chronic kidney diseases (National Institute of Diabetes and Digestive and Kidney Diseases, 2013). Modest weight loss, as little as 5% of total body weight, can help to improve type 2 diabetes in patients who are overweight or obese. Over the past 2 decades, clinicians have found that obese type 2 diabetes mellitus(T2DM) patients receiving bariatric surgery for weight loss show improved glycemic control. Emerging evidence shows that alteration of gastrointestinal tract anatomy changes the intrinsic regulatory mechanism of glucose homeostasis. There are several types of bariatric surgeries including Roux-en-Y gastric bypass, sleeve gastrectomy, gastric banding and biliopancreatic diversion (Lee et al., 2013). Anatomic changes after laparoscopic and endoscopic interventions cause alterations in GI tract neuroendocrine hormone profiles such as ghrelin-related gene products, Glucagon like peptide (GLP1) and Peptide yy (PYY), which mediate further metabolic effect, hence
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diabetes,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 30/05/2018
Actual Last follow-up date 30/05/2018
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 90
Recruitment status Not yet recruiting
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 Selected patients will be divided into two groups (A,B),each one includes 45 obese T2DM patients with body mass index (BMI)>35kg/m2 .Group A will undergo Roux-en-Y gastric bypass and group B will take its antidiabetic treatments either oral hypoglycemic drugs or insulin Stratified allocation where factors such as age, gender,centre, or previous treatment are used in the stratification Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group continue medical antidiabetics For 1 year Continue oral hypoglycemic drug or insulin 45 Dose Comparison
Experimental Group Roux en y gastric bypass Once Small part of stomach connected to terminal ileum to decrease absorption of glucose 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients having biochemical evidence of type 2 diabetes confirmed by the following diagnostic criteria: a- fasting plasma glucose level > 126mg/dl. b- two-hour post prandial plasma glucose level > 200 mg/dl. c- HBAIC > 7.1%. ¿ Poor glycemic control (HBAIC ¿ 7%) inspite of antidiabetic therapy in accordance with good clinical practice. ¿ Obese with BMI>35kg/m2. ¿ Candidate for general anesthesia. ¿ Patients with type I diabetes mellitus. ¿ Patients with BMI<30kg/m2 ¿ Patients who refuse to participate 25 Year(s) 60 Year(s) Male
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
No 20/04/2017 assiut university
Ethics Committee Address
Street address City Postal code Country
Assiut university street assiut Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome blood sugar control during and at the end
Secondary Outcome Blood pressure , quality of life score ,total lipid At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
assiut university Assiut university street assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
assiut university assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine Assiut university street assiut Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
assiut university assiut Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amal abo shoka afrotohayati@yahoo.com 01006220755 Al Ashraf street
City Postal code Country Position/Affiliation
assiut Egypt
Role Name Email Phone Street address
Public Enquiries Amal Abo shoka Afrotohayati@yahoo.com 01006220755 Alazhar street
City Postal code Country Position/Affiliation
Assiut Egypt
Role Name Email Phone Street address
Scientific Enquiries hala el sherif dr-hala-elshereef@yahoo.com 01111188500 Borg Essam elsherif
City Postal code Country Position/Affiliation
assiut Egypt
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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