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

Surgery Clinical Trial

Official title:

Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01251016
• Other study ID #: CAPPesq 1011/09
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: December 5, 2015
• Start date: July 2010
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Surgery

Locations

Country	Name	City	State
Brazil	Clinics Hospital of the University of São Paulo Medical School	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Federal University of São Paulo, Pennington Biomedical Research Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No