- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949687
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
November 2, 2020 updated by: Luciana El-Kadre, Universidade Positivo
Duodenal Ileal Interposition With Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I.
In order to analise the effect on weight loss and glycemic control after 2 years of follow up
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ileal interposition sleeve sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy
|
laparoscopic ileal interposition with sleeve and sympathectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications
Time Frame: 2 YEARS
|
Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
|
2 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2016
Primary Completion (Actual)
March 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 21, 2016
First Submitted That Met QC Criteria
October 27, 2016
First Posted (Estimate)
October 31, 2016
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 37048114.9.0000.0093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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