Metabolic Effects of Gastrointestinal Surgery in T2DM
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Duodenal jejunal bypass plus sleeve gastrectomy
Best medical treatment (Metformin ; gliclazide)
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, metabolic surgery, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Uncontrolled diabetes ( A1c>8%)
- Less than 10 years of history
- Not taking insulin
- Ages between 20 and 65 years old
- BMI between 26-34
Exclusion Criteria:
- previous abdominal surgery
- LADA
- Using insulin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Best medical treatment
Duodenal jejunal bypass plus sleeve gastrectomy
Arm Description
Metformin 2 g/day; gliclazide 30 mg
Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure
Outcomes
Primary Outcome Measures
Hb A1a
Primary endpoints- glycemic control
Secondary Outcome Measures
Systolic and diastolic blood pressure control
fasting glycemic control
Lipidic control
Full Information
NCT ID
NCT01771185
First Posted
January 14, 2013
Last Updated
January 17, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01771185
Brief Title
Metabolic Effects of Gastrointestinal Surgery in T2DM
Official Title
Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, metabolic surgery, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Best medical treatment
Arm Type
Active Comparator
Arm Description
Metformin 2 g/day; gliclazide 30 mg
Arm Title
Duodenal jejunal bypass plus sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Duodenal jejunal bypass plus sleeve gastrectomy
Intervention Description
Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy
Intervention Type
Drug
Intervention Name(s)
Best medical treatment (Metformin ; gliclazide)
Intervention Description
Metformin 2 g/day; gliclazide 30 mg
Primary Outcome Measure Information:
Title
Hb A1a
Description
Primary endpoints- glycemic control
Time Frame
24 mo
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressure control
Time Frame
24 mo
Title
fasting glycemic control
Time Frame
24 months
Title
Lipidic control
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncontrolled diabetes ( A1c>8%)
Less than 10 years of history
Not taking insulin
Ages between 20 and 65 years old
BMI between 26-34
Exclusion Criteria:
previous abdominal surgery
LADA
Using insulin
12. IPD Sharing Statement
Learn more about this trial
Metabolic Effects of Gastrointestinal Surgery in T2DM
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