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

Stopped early · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01197963

Run by

The University of Texas Health Science Center, Houston

People needed

3

Starts

2010-09-01

Expected to finish

2014-02-01

Last updated by the study team

2015-06-12

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• The University of Texas — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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