Status:
TERMINATED
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01197963
Start Date
September 1 2010
End Date
February 1 2014
Last Update
June 12 2015
Active Locations (1)
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1
The University of Texas
Bellaire, Texas, United States, 77494