- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595396
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
51
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 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
No
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
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.
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)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CONBIOETICA09-CEI-001-20160404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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