A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 55
Updated:5/5/2014
Start Date:September 2010
End Date:December 2012
Contact:Anna Tenorio
Email:anna.cecilia.s.tenorio@uth.tmc.edu
Phone:713 486 1350

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The purpose of the study is to determine if by performing surgery we can cure Type II
Diabetes.

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.


Inclusion Criteria:

- age- 21-55 years.

- 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:

- Type I diabetes/juvenile onset

- 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
We found this trial at
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Bellaire, Texas 77494
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Bellaire, TX
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