SurgeryNCT01251016
Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus
An observational study of Surgery, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Severe obese patients with T2DM candidates to Roux-en-Y gastric bypass surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinics Hospital of the University of São Paulo Medical School
São Paulo, São Paulo, 05403-000
Clinics Hospital FMUSP, +55 11 30696000, webmaster@hcnet.usp.br
About this study
Official title: Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass
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.
- Conditions
- Surgery
- Keywords
- Type 2 diabetes mellitus, Y-Roux gastric bypass, Gut hormones, Gene expression, Surgery
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, Federal University of São Paulo
- Responsible party
- Principal investigator, Dan Linetzky Waitzberg, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251016
- Sponsor's protocol ID
- CAPPesq 1011/09
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2010
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lemos GO, Torrinhas RSM, Pino JMV, Calder PC, Heymsfield SB, Machado NM, Waitzberg DL. Preoperative Cer(d18:1/24:0) Shows Promise as a Candidate Predictor of Plasma Lipid Phenotypes Following Roux-en-Y Gastric Bypass in Women: An Exploratory Analysis of the SURMetaGIT Study. J Obes. 2026;2026(1):e2335829. doi: 10.1155/jobe/2335829.
PubMed 42584973Lemos GO, Torrinhas RS, Machado NM, Waitzberg DL. Changes in Plasma Sphingolipid Metabolites Following Roux-En-Y Gastric Bypass in Women With Obesity and Type 2 Diabetes: A Pilot Metabolomic Cohort Study. Lipids. 2026 Mar;61(2):195-205. doi: 10.1002/lipd.70019. Epub 2025 Nov 12.
PubMed 41224249Garla 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.
PubMed 30459098Sala 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.
PubMed 28213664Silva 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.
PubMed 25518027
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01251016
- Acronym / sponsor ID
- CAPPesq 1011/09
- Conditions
- Surgery
- Keywords
- Type 2 diabetes mellitus, Y-Roux gastric bypass, Gut hormones, Gene expression, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, Federal University of São Paulo
- Study start
- Jul 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Severe obese patients with T2DM candidates to Roux-en-Y gastric bypass surgery
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Derived from this study: PubMed 42584973Lemos GO, Torrinhas RSM, Pino JMV, Calder PC, Heymsfield SB, Machado NM, Waitzberg DL. Preoperative Cer(d18:1/24:0) Shows Promise as a Candidate Predictor of Plasma Lipid Phenotypes Following Roux-en-Y Gastric Bypass in Women: An Exploratory Analysis of the SURMetaGIT Study. J Obes. 2026;2026(1):e2335829. doi: 10.1155/jobe/2335829.
- Derived from this study: PubMed 41224249Lemos GO, Torrinhas RS, Machado NM, Waitzberg DL. Changes in Plasma Sphingolipid Metabolites Following Roux-En-Y Gastric Bypass in Women With Obesity and Type 2 Diabetes: A Pilot Metabolomic Cohort Study. Lipids. 2026 Mar;61(2):195-205. doi: 10.1002/lipd.70019. Epub 2025 Nov 12.
- Derived from this study: PubMed 30459098Garla 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.
- Derived from this study: PubMed 28213664Sala 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.
- Derived from this study: PubMed 25518027Silva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinics Hospital of the University of São Paulo Medical School
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Selection (time frame: 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251016, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.