Longitudinal Assessment of Bariatric Surgery Sub-Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Jonathan Purnell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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U01DK066557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01DK066555-08