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Improving Diabetes After Bariatric Surgery (LABS-3)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00676923
First received: May 9, 2008
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Obesity
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LABS-3 Diabetes: Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

serum, plasma


Enrollment: 63
Study Start Date: March 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676923

Locations
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
Study Director: Jonathan Purnell, MD Oregon Health and Science University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00676923     History of Changes
Other Study ID Numbers: DK6657_3b, U01DK066557
Study First Received: May 9, 2008
Last Updated: November 12, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013