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

This study is currently recruiting participants.
Verified February 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Brad Snyder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01197963
First received: September 7, 2010
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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.

Condition Intervention
Type 2 Diabetes Mellitus
 Procedure: Sleeve Gastrectomy and Ileal transposition
Dietary Supplement: dietary and medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Serial Postoperative HgA1c levels [ Time Frame: 1 month intervals for 3 months then every 3 months there after ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Serial Postoperative Lipid Profiles levels [ Time Frame: 1 month for the first 3 months then every 3 months there after ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgical treatment
Surgical treatment of one arm of the patient population.
 Procedure: Sleeve Gastrectomy and Ileal transposition
Laparoscopic sleeve gastrectomy with ileal transposition
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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197963

Contacts
Contact: Anna Tenorio 713 486 1350 anna.cecilia.s.tenorio@uth.tmc.edu
Contact: Connie L Klein, NPC 7138925500 connie.pollard@uth.tmc.edu

Locations
United States, Texas
The University of Texas Recruiting
Bellaire, Texas, United States, 77494
Contact: Anna Tenorio     713-486-1350        
Contact: Connie Klein, NPC     713 892 5500        
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Brad E Snyder, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Brad Snyder, Assistant Professor - Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01197963     History of Changes
Other Study ID Numbers: HSC-MS-9-0122
Study First Received: September 7, 2010
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013