Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

Completed

• Conditions: Bariatric Surgery Candidate; Laparoscopic Gastric Bypass; Obesity; Type2 Diabetes

• Registration Number: NCT04595396
• Lead Sponsor: CARLOS ZERRWECK LOPEZ

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-19
• Last Update Submitted: 2020-10-19
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight Loss	36 months	Measure: % total weight loss

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Tlahuac; 🇲🇽 Mexico City, Mexico