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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, metabolic surgery, insulin resistance

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 14, 2013
    Last Updated
    January 17, 2013
    Sponsor
    University of Sao Paulo
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    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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