Surgical Treatment in Diabetic Patients With Grade 1 Obesity

NCT ID: NCT01857076

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28

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.

Conditions

Obesity; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical

Subject submitted to clinical obesity treatment

Group Type: ACTIVE_COMPARATOR

Clinical

Intervention Type: OTHER

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.

Gastric bypass surgery

Subjects submitted to Gastric Bypass Surgery

Group Type: ACTIVE_COMPARATOR

Gastric bypass surgery

Intervention Type: PROCEDURE

Gastric bypass surgery performed laparoscopically

Surgical ileal transposition with sleeve

Subjects submitted to surgical ileal transposition with sleeve

Group Type: ACTIVE_COMPARATOR

Surgical ileal transposition with sleeve

Intervention Type: PROCEDURE

Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.

Interventions

Gastric bypass surgery

Gastric bypass surgery performed laparoscopically

Intervention Type: PROCEDURE

Surgical ileal transposition with sleeve

Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Cláudia Cozer

Md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Cozer, Md

Role: PRINCIPAL_INVESTIGATOR

Hospital Sírio-Libanês

Locations

Hospital Sírio Libanês Teaching and Research Center

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HSL 2012-01

Identifier Type: OTHER

Identifier Source: secondary_id

00747112.3.0000.5461

Identifier Type: REGISTRY

Identifier Source: secondary_id

HSL 2012-01

Identifier Type: -

Identifier Source: org_study_id