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

This study is currently recruiting participants.
Verified December 2015 by Dan Linetzky Waitzberg, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01251016
First Posted: December 1, 2010
Last Update Posted: December 8, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Pennington Biomedical Research Center
Federal University of São Paulo
Information provided by (Responsible Party):
Dan Linetzky Waitzberg, University of Sao Paulo
  Purpose
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
Surgery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dan Linetzky Waitzberg, University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01251016


Locations
Brazil
Clinics Hospital of the University of São Paulo Medical School Recruiting
São Paulo, Brazil, 05403-000
Contact: Clinics Hospital FMUSP    +55 11 30696000    webmaster@hcnet.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Pennington Biomedical Research Center
Federal University of São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dan Linetzky Waitzberg, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01251016     History of Changes
Other Study ID Numbers: CAPPesq 1011/09
First Submitted: November 30, 2010
First Posted: December 1, 2010
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
Surgery

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