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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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleeve Gastrectomy and Ileal transposition
dietary and medical management
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Surgical treatment

Medically controlled group

Arm Description

Surgical treatment of one arm of the patient population.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 7, 2010
Last Updated
June 11, 2015
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01197963
Brief Title
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
Official Title
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
IRB temporarily halted enrollment
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes. The surgical procedures: a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Other
Arm Description
Surgical treatment of one arm of the patient population.
Arm Title
Medically controlled group
Arm Type
Other
Arm Description
Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.
Intervention Type
Procedure
Intervention Name(s)
Sleeve Gastrectomy and Ileal transposition
Intervention Description
Laparoscopic sleeve gastrectomy with ileal transposition
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary and medical management
Intervention Description
dietary and medical routine management patients are currently following with an endocrinologist.
Primary Outcome Measure Information:
Title
Serial Postoperative HgA1c levels
Description
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.
Time Frame
1 month intervals for 3 months then every 3 months there after
Secondary Outcome Measure Information:
Title
Serial Postoperative Lipid Profiles levels
Description
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.
Time Frame
1 month for the first 3 months then every 3 months there after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad E Snyder, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77494
Country
United States

12. IPD Sharing Statement

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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

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