NCT03394157

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

6.8 years

First QC Date

December 29, 2017

Last Update Submit

June 30, 2020

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI

Outcome Measures

Primary Outcomes (1)

  • excess weight loss

    The percent of excess weight loss was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.

    one year

Secondary Outcomes (1)

  • Resolution of diabetes

    one year

Study Arms (1)

Diabetes Mellitus Type 2 in Obese patients

OTHER

obese patients had metabolic surgery for the treatment for DMT2 .Preoperative data , which including SASI bypass , MGB and Sleeve gastrectomy

Other: metabolic surgery

Interventions

metabolic surgeryOTHER

operation to cure type2 diabetes

Also known as: diabetic surgery
Diabetes Mellitus Type 2 in Obese patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic obese patients

You may not qualify if:

  • patients age above 65 or below 18 years old
  • history of upper laparotomy
  • unfit for anesthesia or laparoscopy
  • major psychological instability
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of Bariatric and Metabolic surgery

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 9, 2018

Study Start

January 1, 2011

Primary Completion

November 1, 2017

Study Completion

December 2, 2017

Last Updated

July 2, 2020

Record last verified: 2020-06