NCT04595396

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6.3 years

First QC Date

October 13, 2020

Last Update Submit

October 19, 2020

Conditions

Type2 DiabetesBariatric Surgery CandidateLaparoscopic Gastric BypassObesity

Keywords

bariatric surgeryobesity class 1metabolic surgerylaparoscopic gastric bypasstype-2 diabetes mellitus

Outcome Measures

Primary Outcomes (12)

  • Weight Loss

    Measure: weight (kilograms)

    12 months

  • Weight Loss

    Measure: weight (kilograms)

    24 months

  • Weight Loss

    Measure: weight (kilograms)

    36 months

  • Weight Loss

    Measure: Body Mass Index

    12 months

  • Weight Loss

    Measure: Body Mass Index

    24 months

  • Weight Loss

    Measure: Body Mass Index

    36 months

  • Weight Loss

    Measure: % excess weight loss

    12 months

  • Weight Loss

    Measure: % excess weight loss

    24 months

  • Weight Loss

    Measure: % excess weight loss

    36 months

  • Weight Loss

    Measure: % total weight loss

    12 months

  • Weight Loss

    Measure: % total weight loss

    24 months

  • Weight Loss

    Measure: % total weight loss

    36 months

Secondary Outcomes (5)

  • Complete Diabetes Remission

    12 months

  • Complete Diabetes Remission

    24 months

  • Complete Diabetes Remission

    36 months

  • Late complications

    After 30 days from surgery

  • Early complications

    First 30 days after surgery

Interventions

Laparoscopic Gastric BypassPROCEDURE

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

Also known as: Roux-en-y gastric bypass

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mexican patients with T2DM submitted to laparoscopic gastric bypass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Tlahuac

Mexico City, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 33598844DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Head of Department.

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

September 1, 2012

Primary Completion

January 1, 2019

Study Completion

December 31, 2019

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)