Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Obesity Clinical Trial

Official title:

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857076
• Other study ID #: HSL 2012-01
• Secondary ID: HSL 2012-0100747
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: August 18, 2015
• Start date: February 2013

Study information

• Verified date: May 2013
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Gastric bypass surgery
Gastric bypass surgery performed laparoscopically
• Surgical ileal transposition with sleeve
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.

Other:
• Clinical
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.

Locations

Country	Name	City	State
Brazil	Hospital Sírio Libanês Teaching and Research Center	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic blood rates	Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.	In 2 years	Yes
Primary	Glycemic blood rates	Comparison of efficacy and safety in glycemic control between the two surgical modalities.	In 2 years	Yes
Primary	Diabetes remission evaluated by patients glycemic rates	Comparison of diabetes remission between the two surgical modalities.	In 2 years	No
Secondary	Weight loss	Comparison of efficacy in the control of overweight in the medical and surgical treatment.	In 2 years.	No
Secondary	Decrease in blood lipid	Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.	In 2 years	No
Secondary	Quality of life evaluation	Comparison of quality of life between the medical and surgical treatment through specific interviews	In 2 years	No
Secondary	Number of Early Adverse Events	Comparison of early complications between the two surgical modalities.	In 2 years	Yes
Secondary	Number os Nutricional Complications	Comparison of nutritional complications between the two surgical modalities.	In 2 years	Yes
Secondary	Number of Late Adverse Events	Comparison of late complications between the two surgical modalities.	In 2 years	Yes