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

June 11, 2015 updated by: Brad Snyder, The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Bellaire, Texas, United States, 77494
        • The University Of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgical treatment
Surgical treatment of one arm of the patient population.
Procedure: Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition
Other: Medically controlled group
Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.
Dietary supplement: dietary and medical management
dietary and medical routine management patients are currently following with an endocrinologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial Postoperative HgA1c levels
Time Frame: 1 month intervals for 3 months then every 3 months there after
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial Postoperative Lipid Profiles levels
Time Frame: 1 month for the first 3 months then every 3 months there after
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Brad E Snyder, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-09-0122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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