Surgical Treatment in Diabetic Patients With Grade 1 Obesity

NCT02949687 | Withdrawn DMC

• 1 other identifier: CAAE 37048114.9.0000.0093
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Surgical Treatment in Diabetic Patients With Grade 1 Obesity

Conditions

Diabetes Mellitus; Obesity

Keywords

ileal interposition; metabolic surgery; diabetes; intra abdominal selective denervation

Outcome Measures

Primary Outcomes (1)

• glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications

  Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications

  2 YEARS

Study Arms (1)

ileal interposition sleeve sympathectomy

EXPERIMENTAL

laparoscopic ileal interposition with sleeve and sympathectomy

Procedure: ileal interposition with sleeve and sympathectomy

Interventions

ileal interposition with sleeve and sympathectomy PROCEDURE

laparoscopic ileal interposition with sleeve and sympathectomy

ileal interposition sleeve sympathectomy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documented diagnosis of type 2 diabetes mellitus
• Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
• Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
• HbA1c\> 8.0%
• Age\> 20 years and \<60 years
• Body mass index (BMI) of 30 35 kg / m²
• Agree to sign the consent form

You may not qualify if:

• Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation \<0.5 ng / ml)
• Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
• Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
• Malignant neoplasm
• Portal hypertension
• Inability to cooperate with segment
• Low capacity of understanding surgery
• Unrealistic expectations of the outcome
• Cognitive impairment
• Current pregnancy
• Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria)
• Chemical dependency or alcoholism (based on DSM-V criteria).

Sponsors & Collaborators

• Universidade Positivo: lead

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Sympathectomy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Denervation; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: invited clinical professor

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 31, 2016
• Study Start: September 20, 2016
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share