Status:
UNKNOWN
Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight
Lead Sponsor:
Hospital Federal de Bonsucesso
Conditions:
Diabetes Mellitus
Obesity
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.
Detailed Description
A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I ...
Eligibility Criteria
Inclusion
- Documented diagnosis of type 2 diabetes mellitus;
- Patients of both sexes treated with oral antidiabetic agents and / or insulins,
- Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks;
- HbA1c\> 7.0%;
- Age\> 20 years and \<65 years;
- Body mass index (BMI) of 25 to 35 kg / m²;
- Agree to sign the consent form;
Exclusion
- Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation \<0.5 ng / ml);
- Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months);
- Malignant neoplasm;
- Portal hypertension;
- Difficulty to cooperate with segment;
- Low ability to understand surgery;
- Unrealistic expectations of results;
- Cognitive deficit;
- Current pregnancy;
- Moderate or severe mood disorder; severe anxiety; eating disorders (based on Substance-Related Disorders DSM-V criteria);
- Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03333642
Start Date
November 27 2017
End Date
July 1 2023
Last Update
October 14 2020
Active Locations (1)
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1
Hospital Federal de Bonsucesso
Rio de Janeiro, Brazil, 21041-020