NCT01251016

Brief Summary

Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to treat severe obesity, and its metabolic benefits can lead to early and complete remission of T2DM, even before a considerable weight loss. We have hypothesized that intestinal anatomic changes may change intestinal genes expression related to glycemic control. The knowledge of mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of action in bowel may eventually help to develop alternative, less invasive and safer surgery for the treatment of T2DM, as well as drug development for the newly targets identified.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

November 30, 2010

Last Update Submit

December 5, 2015

Conditions

Surgery

Keywords

Type 2 diabetes mellitusY-Roux gastric bypassGut hormonesGene expressionSurgery

Outcome Measures

Primary Outcomes (1)

  • Patient Selection

    10 patients fully completed with all biological samples colected in the preoperative and postoperative periods (gastrointestinal tissue). RNA extraction of gastrointestinal samples is being performed.

    2013

Eligibility Criteria

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

Severe obese patients with T2DM candidates to Roux-en-Y gastric bypass surgery

You may qualify if:

  • Type 2 diabetes mellitus (T2DM) diagnosis Duration of T2DM \>5 years Use of oral antidiabetic agents Body Mass Index \>40 kg/m2 Candidates to Roux-en-Y gastric bypass

You may not qualify if:

  • Type 1 diabetes mellitus or non-diabetics Use of insulin Thyroid diseases Candidate to other surgery technique Body Mass Index \<40 kg/m2 Presence of bacterium H. Pylori

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital of the University of São Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (4)

  • Lemos GO, Torrinhas RS, Machado NM, Waitzberg DL. Changes in Plasma Sphingolipid Metabolites Following Roux-En-Y Gastric Bypass in Women With Obesity and Type 2 Diabetes: A Pilot Metabolomic Cohort Study. Lipids. 2025 Nov 12. doi: 10.1002/lipd.70019. Online ahead of print.

    PMID: 41224249DERIVED

  • Garla P, Sala P, Torrinhas RSM, Machado NM, Fonseca DC, da Silva MM, Ravacci GR, Belarmino G, Ishida RK, Guarda IFMS, de Moura EGH, Sakai P, Santo MA, da Silva IDCG, Pereira CCA, Heymsfield S, Correa-Giannella MLC, Calder PC, Waitzberg DL. Reduced intestinal FADS1 gene expression and plasma omega-3 fatty acids following Roux-en-Y gastric bypass. Clin Nutr. 2019 Jun;38(3):1280-1288. doi: 10.1016/j.clnu.2018.05.011. Epub 2018 May 29.

    PMID: 30459098DERIVED

  • Sala P, Torrinhas RS, Fonseca DC, Heymsfield S, Giannella-Neto D, Waitzberg DL. Type 2 Diabetes Remission After Roux-en-Y Gastric Bypass: Evidence for Increased Expression of Jejunal Genes Encoding Regenerating Pancreatic Islet-Derived Proteins as a Potential Mechanism. Obes Surg. 2017 Apr;27(4):1123-1127. doi: 10.1007/s11695-017-2602-0.

    PMID: 28213664DERIVED

  • Silva MM, Sala PC, Cardinelli CS, Torrinhas RS, Waitzberg DL. Comparison of Virtual Nutri Plus(R) and Dietpro 5i(R) software systems for the assessment of nutrient intake before and after Roux-en-Y gastric bypass. Clinics (Sao Paulo). 2014 Nov;69(11):714-22. doi: 10.6061/clinics/2014(11)02.

    PMID: 25518027DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 1, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

BR(1)