Expired Study
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Pittsburgh, Pennsylvania 15213


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.


Study summary:

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.


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).


Study is Available At:


Original ID:

DK6657_3b


NCT ID:

NCT00676923


Secondary ID:

U01DK066557


Study Acronym:

LABS-3


Brief Title:

Improving Diabetes After Bariatric Surgery


Official Title:

LABS-3 Diabetes: Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan Purnell, MD
Study Director
Oregon Health and Science University

Study Dates

Start Date:March 2008
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 12, 2012
First Received Date:May 9, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Samples and Retentions

Sample Retention:Samples Without DNA
Description: serum, plasma
Study Population: Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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