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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01197963
• Other study ID #: HSC-MS-09-0122
• Status: Terminated
• Phase: N/A
• First received: September 7, 2010
• Last updated: June 11, 2015
• Start date: September 2010
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition

Dietary Supplement:
• dietary and medical management
dietary and medical routine management patients are currently following with an endocrinologist.

Locations

Country	Name	City	State
United States	The University of Texas	Bellaire	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial Postoperative HgA1c levels	Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(<110 mg/dl) normal HbA1c (<6%) and no need for diabetic medications.	1 month intervals for 3 months then every 3 months there after	No
Secondary	Serial Postoperative Lipid Profiles levels	Lipid profiles will be examined at follow up witha goal of total cholesterol <200 mg/dl, low-density lipoprotein (LDL) levels <100 mg/dl, triglyceride levels <150 mg/dl, and high-density lipoprotein (HDL) levels >40 mg/dl. Patients will be fasting for 8 hours and the serum glucose and GLP-1 level will be checked.	1 month for the first 3 months then every 3 months there after	No