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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
tarek mahdy
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 29, 2017
    Last Updated
    June 30, 2020
    Sponsor
    tarek mahdy
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    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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