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Improving Diabetes After Bariatric Surgery (LABS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676923
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh

Study Description
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Brief Summary:
The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Condition or disease
Obesity Diabetes

Detailed Description:

The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.

Funds are not available to pay for the surgery for patients, only to address research questions.

Study Design
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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LABS-3 Diabetes: Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery
Study Start Date : March 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples Without DNA
serum, plasma

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.
Criteria

Inclusion Criteria:

  • Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
  • Enrollment in LABS-1 or LABS-2.
  • Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
  • Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
  • Adequate IV access.

Exclusion Criteria:

  • Informed consent not obtained.
  • Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
  • Creatinine greater than 1.7.
  • Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
  • Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676923


Locations
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United States, Oregon
Legacy Good Samaritan Hospital
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Director: Jonathan Purnell, MD Oregon Health and Science University
More Information
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Additional Information:

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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00676923    
Other Study ID Numbers: DK6657_3b
U01DK066557 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases