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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. (see Contacts and Locations)
Verified November 2010 by University of Sao Paulo
Sponsor:
Collaborators:
Pennington Biomedical Research Center
Federal University of São Paulo
Information provided by (Responsible Party):
Dan Linetzky Waitzberg, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01251016
First received: November 30, 2010
Last updated: May 19, 2014
Last verified: November 2010
  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 University of Sao Paulo:

Primary Outcome Measures:
  • Patient Selection [ Time Frame: 2013 ] [ Designated as safety issue: No ]
    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 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 30, 2010
Last Updated: May 19, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by 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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014