ObesityNCT01857076
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
A study testing Gastric bypass surgery, Surgical ileal transposition with sleeve and Clinical in people with Obesity and Type 2 Diabetes Mellitus, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Gastric bypass surgery, Surgical ileal transposition with sleeve and Clinical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to May 2015
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman with Type 2 diabetes mellitus (DM) aged between 25 and 65 years, with time since diagnosis of diabetes less than 10 years.
- Grade I obesity (BMI between 30-35)
- Inadequate glycemic control with HbA1c between 7.0 to 9.5% at baseline, in the presence of drug treatment for diabetes in the last year.
- Reserve pancreatic C-peptide> 1.0 at baseline.
- Overweight stable defined as BMI> 30 in the last two years.
Who cannot join
- History ketoacidosis, diabetes mellitus type 1, diabetes followed by pancreatitis.
- Repetition of measurements (ie, 2 or more within 1 week) fasting plasma glucose(FPG) > 240 mg / dL during the pre-treatment.
- History of Severe Proliferative Diabetic Retinopathy.
- Autonomic neuropathy.
- Loss or gain significant weight within the last 12 weeks (range, 5% body weight)
- Renal insufficiency
Show all 20Show fewer
- History of renal disease treated with immunosuppressive therapy, history of dialysis or kidney transplantation.
- Presence of other renal diseases (eg nephrotic syndrome, glomerulonephritis)
- Acute myocardial infarction, unstable angina (NYHA class III-IV), revascularization or stroke within the previous 3 months of the initial visit.
- Uncontrolled hypertension defined as diastolic blood pressure> 100mm/Hg and diastolic blood pressure> 160mm/Hg at the initial visit.
- History of Hepatitis B or Hepatitis C.
- Criteria for Hepatic insufficiency defined as Child B and C liver disease clinically active and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above 3 times the upper limit of normal.
- History of prior bariatric surgery.
- Inflammatory Bowel Disease.
- History neoplasm within the last 5 years (except for squamous cell carcinoma and basal skin and cervical carcinoma in situ)
- Clinically important hematologic disorder (symptomatic anemia, bone marrow proliferative disorders, thrombocytopenia, ..)
- History antibody positive human immunodeficiency virus (HIV)
- Surgery with general anesthesia within 12 weeks prior to the initial visit or incomplete recovery from prior surgery.
- History of drug or alcohol abuse within 3 years before the initial visit.
- Pregnancy or breastfeeding or planning pregnancy in the next two years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Sírio Libanês Teaching and Research Center
São Paulo, São Paulo, 01308060
About this study
There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Gastric bypass surgery, Surgical ileal transposition with sleeve, Clinical
- Keywords
- Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypass surgeryProcedure or surgery
Gastric bypass surgery performed laparoscopically
Surgical ileal transposition with sleeveProcedure or surgery
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
ClinicalOther
The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results.
| Study group | Role | What they receive |
|---|---|---|
| Clinical | Active comparator | Subject submitted to clinical obesity treatment Receives: Other: Clinical |
| Gastric bypass surgery | Active comparator | Subjects submitted to Gastric Bypass Surgery Receives: Procedure: Gastric bypass surgery |
| Surgical ileal transposition with sleeve | Active comparator | Subjects submitted to surgical ileal transposition with sleeve Receives: Procedure: Surgical ileal transposition with sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Measured: In 2 years
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Measured: In 2 years
Diabetes remission evaluated by patients glycemic rates
Comparison of diabetes remission between the two surgical modalities.
Measured: In 2 years
Secondary outcomes (6)
Weight loss
Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Measured: In 2 years.
Decrease in blood lipid
Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Measured: In 2 years
Quality of life evaluation
Comparison of quality of life between the medical and surgical treatment through specific interviews
Measured: In 2 years
Number of Early Adverse Events
Comparison of early complications between the two surgical modalities.
Measured: In 2 years
Number os Nutricional Complications
Comparison of nutritional complications between the two surgical modalities.
Measured: In 2 years
Number of Late Adverse Events
Comparison of late complications between the two surgical modalities.
Measured: In 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Cozer, Hospital Sirio-Libanes
- Investigators
- Claudia Cozer, Md, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857076
- Sponsor's protocol ID
- HSL 2012-01
- Other IDs
- HSL 2012-01, 00747112.3.0000.5461
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment in Diabetic Patients With Grade 1 Obesity
- ClinicalTrials.gov ID
- NCT01857076
- Acronym / sponsor ID
- HSL 2012-01
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- First posted
- 20 May 2013 (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.
There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical | Active comparator | Other: ClinicalSubject submitted to clinical obesity treatment |
| Gastric bypass surgery | Active comparator | Procedure: Gastric bypass surgerySubjects submitted to Gastric Bypass Surgery |
| Surgical ileal transposition with sleeve | Active comparator | Procedure: Surgical ileal transposition with sleeveSubjects submitted to surgical ileal transposition with sleeve |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman with Type 2 diabetes mellitus (DM) aged between 25 and 65 years, with time since diagnosis of diabetes less than 10 years.
- Grade I obesity (BMI between 30-35)
- Inadequate glycemic control with HbA1c between 7.0 to 9.5% at baseline, in the presence of drug treatment for diabetes in the last year.
- Reserve pancreatic C-peptide> 1.0 at baseline.
- Overweight stable defined as BMI> 30 in the last two years.
Key exclusion criteria (20 listed)
- History ketoacidosis, diabetes mellitus type 1, diabetes followed by pancreatitis.
- Repetition of measurements (ie, 2 or more within 1 week) fasting plasma glucose(FPG) > 240 mg / dL during the pre-treatment.
- History of Severe Proliferative Diabetic Retinopathy.
- Autonomic neuropathy.
- Loss or gain significant weight within the last 12 weeks (range, 5% body weight)
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 |
|---|---|---|
| Gastric bypass surgeryGastric bypass surgery performed laparoscopically | Procedure or surgery | Gastric bypass surgery |
| Surgical ileal transposition with sleeveSurgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery. | Procedure or surgery | Surgical ileal transposition with sleeve |
| ClinicalThe study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results. | Other | Clinical |
Primary outcome
Glycemic blood rates
Time frame: In 2 years
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Glycemic blood rates
Time frame: In 2 years
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Diabetes remission evaluated by patients glycemic rates
Time frame: In 2 years
Comparison of diabetes remission between the two surgical modalities.
6 secondary outcomes
Weight loss
Time frame: In 2 years.
Decrease in blood lipid
Time frame: In 2 years
Quality of life evaluation
Time frame: In 2 years
Number of Early Adverse Events
Time frame: In 2 years
Number os Nutricional Complications
Time frame: In 2 years
Number of Late Adverse Events
Time frame: In 2 years
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 20 Aug 2015.
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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.
Claudia Cozer, Md principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass surgery, Surgical ileal transposition with sleeve and Clinical in people with Obesity and Type 2 Diabetes Mellitus, run by Hospital Sirio-Libanes 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 5 inclusion and 20 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 20 Aug 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?
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?
Glycemic blood rates (time frame: In 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2015.