Surgical Treatment in Diabetic Patients With Grade 1 Obesity
2 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedAugust 20, 2015
May 1, 2013
2.2 years
May 7, 2013
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
In 2 years
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
In 2 years
Diabetes remission evaluated by patients glycemic rates
Comparison of diabetes remission between the two surgical modalities.
In 2 years
Secondary Outcomes (6)
Weight loss
In 2 years.
Decrease in blood lipid
In 2 years
Quality of life evaluation
In 2 years
Number of Early Adverse Events
In 2 years
Number os Nutricional Complications
In 2 years
- +1 more secondary outcomes
Study Arms (3)
Clinical
ACTIVE COMPARATORSubject submitted to clinical obesity treatment
Gastric bypass surgery
ACTIVE COMPARATORSubjects submitted to Gastric Bypass Surgery
Surgical ileal transposition with sleeve
ACTIVE COMPARATORSubjects submitted to surgical ileal transposition with sleeve
Interventions
Gastric bypass surgery performed laparoscopically
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Sírio Libanês Teaching and Research Center
São Paulo, São Paulo, 01308060, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Cozer, Md
Hospital Sírio-Libanês
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md
Study Record Dates
First Submitted
May 7, 2013
First Posted
May 20, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Last Updated
August 20, 2015
Record last verified: 2013-05