Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

October 19, 2020 updated by: CARLOS ZERRWECK LOPEZ

Gastric Bypass as Metabolic Surgery in Obesity Class 1: a Prospective Study of the Short, Mid and Long Term Results Among Mexicans

Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Laparoscopic Gastric Bypass

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- - Mexico City, Mexico
    - Hospital General Tlahuac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mexican patients with T2DM submitted to laparoscopic gastric bypass

Description

Inclusion criteria Any sex >18 years-old <60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass

Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss Time Frame: 12 months	Measure: weight (kilograms)	12 months
Weight Loss Time Frame: 24 months	Measure: weight (kilograms)	24 months
Weight Loss Time Frame: 36 months	Measure: weight (kilograms)	36 months
Weight Loss Time Frame: 12 months	Measure: Body Mass Index	12 months
Weight Loss Time Frame: 24 months	Measure: Body Mass Index	24 months
Weight Loss Time Frame: 36 months	Measure: Body Mass Index	36 months
Weight Loss Time Frame: 12 months	Measure: % excess weight loss	12 months
Weight Loss Time Frame: 24 months	Measure: % excess weight loss	24 months
Weight Loss Time Frame: 36 months	Measure: % excess weight loss	36 months
Weight Loss Time Frame: 12 months	Measure: % total weight loss	12 months
Weight Loss Time Frame: 24 months	Measure: % total weight loss	24 months
Weight Loss Time Frame: 36 months	Measure: % total weight loss	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Diabetes Remission Time Frame: 12 months	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	12 months
Complete Diabetes Remission Time Frame: 24 months	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	24 months
Complete Diabetes Remission Time Frame: 36 months	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	36 months
Late complications Time Frame: After 30 days from surgery	Complications requiring re-admssion / re-operation	After 30 days from surgery
Early complications Time Frame: First 30 days after surgery	Complications requiring re-admssion / re-operation	First 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CARLOS ZERRWECK LOPEZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Cevallos L, Rodriguez FM, Herrera A, Sepulveda EM, Donatini G, Guilbert L, Zerrweck C. Metabolic Surgery and Class 1 Obesity (< 35 kg/m2): a Prospective Study with Short-, Mid-, and Long-term Results Among Latinos. Obes Surg. 2021 Jun;31(6):2401-2409. doi: 10.1007/s11695-021-05275-3. Epub 2021 Feb 17.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)