Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595396
• Other study ID #: CONBIOETICA09-CEI-001-20160404
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Hospital General Tlahuac
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus, Type 2
• Laparoscopic Gastric Bypass
• Obesity
• Type2 Diabetes

Intervention

Procedure:
• Laparoscopic Gastric Bypass
The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ˜70 cm and ˜150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case

Locations

Country	Name	City	State
Mexico	Hospital General Tlahuac	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
CARLOS ZERRWECK LOPEZ

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	Measure: weight (kilograms)	12 months
Primary	Weight Loss	Measure: weight (kilograms)	24 months
Primary	Weight Loss	Measure: weight (kilograms)	36 months
Primary	Weight Loss	Measure: Body Mass Index	12 months
Primary	Weight Loss	Measure: Body Mass Index	24 months
Primary	Weight Loss	Measure: Body Mass Index	36 months
Primary	Weight Loss	Measure: % excess weight loss	12 months
Primary	Weight Loss	Measure: % excess weight loss	24 months
Primary	Weight Loss	Measure: % excess weight loss	36 months
Primary	Weight Loss	Measure: % total weight loss	12 months
Primary	Weight Loss	Measure: % total weight loss	24 months
Primary	Weight Loss	Measure: % total weight loss	36 months
Secondary	Complete Diabetes Remission	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	12 months
Secondary	Complete Diabetes Remission	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	24 months
Secondary	Complete Diabetes Remission	Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6	36 months
Secondary	Late complications	Complications requiring re-admssion / re-operation	After 30 days from surgery
Secondary	Early complications	Complications requiring re-admssion / re-operation	First 30 days after surgery