Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study
Primary Purpose
Diabetes Mellitus Type 2 in Obese
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metabolic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 in Obese focused on measuring sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic obese patients
Exclusion Criteria:
- patients age above 65 or below 18 years old
- history of upper laparotomy
- unfit for anesthesia or laparoscopy
- major psychological instability
- drug abuse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diabetes Mellitus Type 2 in Obese patients
Arm Description
obese patients had metabolic surgery for the treatment for DMT2 .Preoperative data , which including SASI bypass , MGB and Sleeve gastrectomy
Outcomes
Primary Outcome Measures
excess weight loss
The percent of excess weight loss was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.
Secondary Outcome Measures
Resolution of diabetes
defined in this study as a fasting plasma glucose level < 110 mg/dL or HbA1C level < 6 % without hypoglycemic medication at 1 year after surgery. whereas improvement was defined as a reduction of at least 25% in the fasting plasma glucose level and of at least 1% in the hemoglobin A1c level with hypoglycemic drug treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03394157
Brief Title
Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study
Official Title
Efficacy of Sleeve Gastrectomy, MGB, SASI Bypass in Type 2 Diabetes Obese Patients, Comparative Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
December 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
tarek mahdy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the investigator Randomized and compare the efficacy of 3 types of metabolic surgery in the treatment of type 2 diabetes in obese patients, one of them is SASI bypass which is a modification of Santoro's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first comparative clinical trial as regards the clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes.
Detailed Description
from 2011 to 2017, investigators Randomized and collect data for the 3 operations SASI bypass , Mini gastric bypass and Sleeve gastrectomy ) about thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude gall stones and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity complications and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Obese
Keywords
sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Mellitus Type 2 in Obese patients
Arm Type
Other
Arm Description
obese patients had metabolic surgery for the treatment for DMT2 .Preoperative data , which including SASI bypass , MGB and Sleeve gastrectomy
Intervention Type
Other
Intervention Name(s)
metabolic surgery
Other Intervention Name(s)
diabetic surgery
Intervention Description
operation to cure type2 diabetes
Primary Outcome Measure Information:
Title
excess weight loss
Description
The percent of excess weight loss was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Resolution of diabetes
Description
defined in this study as a fasting plasma glucose level < 110 mg/dL or HbA1C level < 6 % without hypoglycemic medication at 1 year after surgery. whereas improvement was defined as a reduction of at least 25% in the fasting plasma glucose level and of at least 1% in the hemoglobin A1c level with hypoglycemic drug treatment
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic obese patients
Exclusion Criteria:
patients age above 65 or below 18 years old
history of upper laparotomy
unfit for anesthesia or laparoscopy
major psychological instability
drug abuse
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study
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