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Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus

NCT ID: NCT01251016

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Dan Linetzky Waitzberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinics Hospital of the University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Clinics Hospital FMUSP

Role: primary

[email protected]
+55 11 30696000

References

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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.

Reference Type DERIVED
PMID: 30459098 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28213664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25518027 (View on PubMed)

Other Identifiers

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CAPPesq 1011/09

Identifier Type: -

Identifier Source: org_study_id