Improving Diabetes After Bariatric Surgery - Full Text View

Improving Diabetes After Bariatric Surgery (LABS-3)

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008

First Received: May 9, 2008 Last Updated: December 8, 2008 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00676923

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

MedlinePlus related topics: Diabetes Obesity Surgery Weight Loss Surgery

U.S. FDA Resources

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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum, plasma

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (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

Contacts

Contact: Steven Belle, PhD

412-624-9640

belle@edc.pitt.edu

Locations

United States, Oregon
Legacy Good Samaritan Hospital	Recruiting
Portland, Oregon, United States
Principal Investigator: Bruce Wolfe, MD
Oregon Health and Science University	Recruiting
Portland, Oregon, United States
Principal Investigator: Bruce Wolfe, MD
United States, Pennsylvania
University of Pittsburgh Medical Center	Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: David R Flum, MD,MPH,FACS
Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: David R. Flum, MD,MPH,FACS

Sponsors and Collaborators

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:	Oregon Health & Science University ( Dr. Bruce Wolfe, LABS Steering Committee Chair )
Study ID Numbers:	DK6657_3b
Study First Received:	May 9, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00676923 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009