A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
NCT ID: NCT01197963
Last Updated: 2015-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2010-09-30
2014-02-28
Brief Summary
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The surgical procedures:
1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
2. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgical treatment
Surgical treatment of one arm of the patient population.
Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition
Medically controlled group
Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.
dietary and medical management
dietary and medical routine management patients are currently following with an endocrinologist.
Interventions
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Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition
dietary and medical management
dietary and medical routine management patients are currently following with an endocrinologist.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index between 25-35 kf/m2.
* currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
* Documented HbA1c\>7.5% for at least 3 months.
* Stable weight for 3 months (+/-)
* Evidence of stable medical treatment for diabetes over the past 12 months.
* Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -
Exclusion Criteria
* C-Peptid levels below 1.0 ng/ml
* Previous major upper abdominal surgery
--Pregnant or plans to become pregnant with in the next 12 months
* Current Malignancy
* Severe pulmonary, cardia, or renal disease
* Eating disorders such as bulimia or binge-eating
* Severe mental health disorders such as schizophrenia and bipolar disorder
* Obesity due to other metabolic disorders
* taking appetite suppressants
* currently abusing illicit drugs,alcohol or using tobacco products
* Unable to provide informed consent
* Unwillingness or unable to comply with study procedures
* any condition that deems them unsuitable for the study in the opinion of the investigators
21 Years
55 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Brad Snyder
Assistant Professor - Surgery
Principal Investigators
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Brad E Snyder, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas
Bellaire, Texas, United States
Countries
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Other Identifiers
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HSC-MS-09-0122
Identifier Type: -
Identifier Source: org_study_id
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