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

The University of Texas System (UT)

Status: Terminated

Conditions: Type 2 Diabetes Mellitus

Treatments: Procedure: Sleeve Gastrectomy and Ileal transposition; Dietary Supplement: dietary and medical management

Study type: Interventional

Funder types: Other

Identifiers

NCT01197963

HSC-MS-09-0122

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Surgical treatment

Other group

Description:

Surgical treatment of one arm of the patient population.

Treatment:

Procedure: Sleeve Gastrectomy and Ileal transposition

Medically controlled group

Other group

Description:

Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.

Treatment:

Dietary Supplement: dietary and medical management