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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251016
Recruitment Status : Unknown
Verified December 2015 by Dan Linetzky Waitzberg, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 1, 2010
Last Update Posted : December 8, 2015
Pennington Biomedical Research Center
Federal University of São Paulo
Information provided by (Responsible Party):
Dan Linetzky Waitzberg, University of Sao Paulo

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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass
Study Start Date : July 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patient Selection [ Time Frame: 2013 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe obese patients with T2DM candidates to Roux-en-Y gastric bypass surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251016

Clinics Hospital of the University of São Paulo Medical School Recruiting
São Paulo, Brazil, 05403-000
Contact: Clinics Hospital FMUSP    +55 11 30696000   
Sponsors and Collaborators
University of Sao Paulo
Pennington Biomedical Research Center
Federal University of São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dan Linetzky Waitzberg, Associate Professor, University of Sao Paulo Identifier: NCT01251016     History of Changes
Other Study ID Numbers: CAPPesq 1011/09
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Dan Linetzky Waitzberg, University of Sao Paulo:
Type 2 diabetes mellitus
Y-Roux gastric bypass
Gut hormones
Gene expression

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases