Diabetes MellitusADIIINCT01581099
Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk
An observational study of Diabetes Mellitus and Metabolic Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Metabolic Syndrome, Obesity
- What is being tested?
- Digestive Adaptations III surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to 20 Apr 2017
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be selected in a primary care clinic.
Who may be able to join
- Men.
- Adults (raging from 18 to 65 years).
- Ability to understand the procedure, risks and alternatives.
- Patients with BMI > 28 Kg/m2 and < 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
- Glycated hemoglobin> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
- Waist circumference > 102 cm.
Who cannot join
- Chronic diseases not related to severe obesity.
- Pregnancy.
- Peptide C <1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA512.
- Previous cancer, unless deemed cured (after 5 years of treatment, at least)
- Acute infection or chronic relevant.
- Alcohol addiction.
- Tobacco use.
- Drug addiction, except those recovered for more than three years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors
Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.
Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.
Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Atherosclerosis
- Being tested
- Digestive Adaptations III surgery
- Keywords
- Atherosclerosis, Cardiovascular risk factors, Calorie restriction, Bariatric Surgery
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive Adaptations III surgeryProcedure or surgery
Also called Sleeve gastrectomy with transit bipartition
| Study group | Role | What they receive |
|---|---|---|
| Clinical treatment | Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle | |
| Surgery | Diabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery. Receives: Procedure: Digestive Adaptations III surgery | |
| Control | Healthy individuals (normal weight and no cardiovascular risk factors) will be used to evaluate the behavior incretin hormones in healthy individuals, serving as a benchmark to analyze the results obtained in other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Metabolic Profile
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Bruno Caramelli, University of Sao Paulo
- Investigators
- Bruno Caramelli, Ph.D., Study chair, University of Sao PauloFernanda R Azevedo, Nutr, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581099
- Sponsor's protocol ID
- USP - 0355/11
- Acronym
- ADIII
- Status last verified
- May 2017
- First submitted
- 17 Apr 2012
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Azevedo FR, Santoro S, Correa-Giannella ML, Toyoshima MT, Giannella-Neto D, Calderaro D, Gualandro DM, Yu PC, Caramelli B. A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition. Obes Surg. 2018 Oct;28(10):3012-3019. doi: 10.1007/s11695-018-3239-3.
PubMed 29704228
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery "Digestive Adaptations III" on Clinical, Laboratory and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01581099
- Acronym / sponsor ID
- ADIII / USP - 0355/11
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Atherosclerosis
- Keywords
- Atherosclerosis, Cardiovascular risk factors, Calorie restriction, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 19 Apr 2012 (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.
Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established.
Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors.
Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical treatment | – | –Diabetic individuals refractory to medical treatment kept under clinical treatment guidelines and lifestyle |
| Surgery | – | Procedure: Digestive Adaptations III surgeryDiabetic individuals refractory to conservative clinical treatment subject to Digestive Adaptations III Surgery. |
| Control | – | –Healthy individuals (normal weight and no cardiovascular risk factors) will be used to evaluate the behavior incretin hormones in healthy individuals, serving as a benchmark to analyze the results obtained in other groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected in a primary care clinic.
Key inclusion criteria (6 listed)
- Men.
- Adults (raging from 18 to 65 years).
- Ability to understand the procedure, risks and alternatives.
- Patients with BMI > 28 Kg/m2 and < 35 Kg/m2 presenting type 2 diabetes diagnosed for more than two years and less than 10 years.
- Glycated hemoglobin> 8% despite dietary and medical treatment that already includes the use of exogenous insulin
Key exclusion criteria (8 listed)
- Chronic diseases not related to severe obesity.
- Pregnancy.
- Peptide C <1.5 ng / mL or a positive anti-islet antibodies, anti-GAD or anti-ICA512.
- Previous cancer, unless deemed cured (after 5 years of treatment, at least)
- Acute infection or chronic relevant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digestive Adaptations III surgeryAlso: Sleeve gastrectomy with transit bipartition | Procedure or surgery | Surgery |
Primary outcome
Improvement in Metabolic Profile
Time frame: two years
Modification in variables linked to cardiovascular diseases leading to an estimated reduction in cardiovascular risk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 29704228Azevedo FR, Santoro S, Correa-Giannella ML, Toyoshima MT, Giannella-Neto D, Calderaro D, Gualandro DM, Yu PC, Caramelli B. A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition. Obes Surg. 2018 Oct;28(10):3012-3019. doi: 10.1007/s11695-018-3239-3.
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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.
Bruno Caramelli, Ph.D. study chair
University of Sao Paulo
Fernanda R Azevedo, Nutr principal investigator
University of Sao Paulo
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 Diabetes Mellitus and Metabolic Syndrome, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Metabolic Profile (time frame: two years). 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 NCT01581099, which also lists 1 linked publication.
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 2 May 2017.