Longitudinal Assessment of Bariatric Surgery Sub-Study (LABS-3)

December 14, 2022 updated by: Jonathan Purnell, Oregon Health and Science University

Longitudinal Assessment of Bariatric Surgery Sub-Study: A Prospective, Longitudinal Cohort Study of the Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (LABS-3 DIABETES)

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 Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

39

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Up to 72 months
Weight measurements will take place at every visit, up to 72 months after bariatric surgery.
Up to 72 months
Capillary Blood Glucose
Time Frame: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

February 15, 2021

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00003207
  • U01DK066557 (U.S. NIH Grant/Contract)
  • U01DK066555-08 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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