Clinical trial NCT01251016: Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus
Official title: Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Keywords: Type 2 diabetes mellitus
Y-Roux gastric bypass
Gut hormones
Gene expression
Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
name: Federal University of São Paulo
First posted: 2010-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe obese patients with T2DM candidates to Roux-en-Y gastric bypass surgery

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.


Eligibility 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

Primary outcomes:
measure: Patient Selection
timeFrame: 2013
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinics Hospital of the University of São Paulo Medical School
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.