Back to resultsSurgical Treatment in Diabetic Patients With Grade 1 Obesity
Primary Purpose
Obesity, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gastric bypass surgery
Surgical ileal transposition with sleeve
Clinical
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Hospital Sírio Libanês Teaching and Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Clinical
Gastric bypass surgery
Surgical ileal transposition with sleeve
Arm Description
Subject submitted to clinical obesity treatment
Subjects submitted to Gastric Bypass Surgery
Subjects submitted to surgical ileal transposition with sleeve
Outcomes
Primary Outcome Measures
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Diabetes remission evaluated by patients glycemic rates
Comparison of diabetes remission between the two surgical modalities.
Secondary Outcome Measures
Weight loss
Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Decrease in blood lipid
Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Quality of life evaluation
Comparison of quality of life between the medical and surgical treatment through specific interviews
Number of Early Adverse Events
Comparison of early complications between the two surgical modalities.
Number os Nutricional Complications
Comparison of nutritional complications between the two surgical modalities.
Number of Late Adverse Events
Comparison of late complications between the two surgical modalities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01857076
Brief Title
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Official Title
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes mellitus, Grade I obesity, Inadequate glycemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical
Arm Type
Active Comparator
Arm Description
Subject submitted to clinical obesity treatment
Arm Title
Gastric bypass surgery
Arm Type
Active Comparator
Arm Description
Subjects submitted to Gastric Bypass Surgery
Arm Title
Surgical ileal transposition with sleeve
Arm Type
Active Comparator
Arm Description
Subjects submitted to surgical ileal transposition with sleeve
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass surgery
Intervention Description
Gastric bypass surgery performed laparoscopically
Intervention Type
Procedure
Intervention Name(s)
Surgical ileal transposition with sleeve
Intervention Description
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
Intervention Type
Other
Intervention Name(s)
Clinical
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic blood rates
Description
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Time Frame
In 2 years
Title
Glycemic blood rates
Description
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Time Frame
In 2 years
Title
Diabetes remission evaluated by patients glycemic rates
Description
Comparison of diabetes remission between the two surgical modalities.
Time Frame
In 2 years
Secondary Outcome Measure Information:
Title
Weight loss
Description
Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Time Frame
In 2 years.
Title
Decrease in blood lipid
Description
Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Time Frame
In 2 years
Title
Quality of life evaluation
Description
Comparison of quality of life between the medical and surgical treatment through specific interviews
Time Frame
In 2 years
Title
Number of Early Adverse Events
Description
Comparison of early complications between the two surgical modalities.
Time Frame
In 2 years
Title
Number os Nutricional Complications
Description
Comparison of nutritional complications between the two surgical modalities.
Time Frame
In 2 years
Title
Number of Late Adverse Events
Description
Comparison of late complications between the two surgical modalities.
Time Frame
In 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Cozer, Md
Organizational Affiliation
Hospital Sírio-Libanês
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sírio Libanês Teaching and Research Center
City
São Paulo
ZIP/Postal Code
01308060
Country
Brazil
12. IPD Sharing Statement
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Surgical Treatment in Diabetic Patients With Grade 1 Obesity
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