Mechanisms of Diabetes Relapse After Bariatric Surgery



Status:Not yet recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:July 2015
End Date:July 2017
Contact:Blandine Laferrere, MD
Email:bbl14@cumc.columbia.edu

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The purpose of this study is to understand the mechanisms of type 2 diabetes remission and
relapse after Gastric Bypass Surgery (GBP). The investigators will be studying the effect of
glucose and hormones on the production of insulin.

The investigators expect to find that individuals who have a relapse of diabetes after GBP
have a weaker insulin secretion response to various stimuli. Subjects with Diabetes relapse
will also be less sensitive to insulin, and will have more body fat.

The purpose of this study is to understand the mechanisms of type 2 diabetes remission and
relapse after Gastric Bypass Surgery (GBP).

In this cross sectional study, three groups will be studied:

1. Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes
prior to GBP and currently have persistent or relapsed diabetes.

2. Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes
prior to GBP and are currently in full diabetes remission.

3. Overweight or moderately obese patients without any diabetes, who have not undergone
bariatric surgery.

At the New York Obesity Research Center of St. Luke's Roosevelt Hospital Center in New York
City, The investigators will study approximately 12-15 patients from each of these groups
for a total of approximately 40 patients.

Patients will have four appointments each, which will take place over the course of
approximately 2 to 8 weeks. Over the four visits the investigators will assess insulin
secretion in response to oral and various intravenous nutrient or hormonal stimuli. Body
composition will be assessed to look at fat mass and distribution.

Inclusion Criteria: Post GBP Subjects

- Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in
Manhattan, New York City

- At least 1 year post GBP surgery

- History of Type 2 Diabetes before surgery

Inclusion Criteria: Non-Operated Overweight to Moderately Obese Controls

- Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in
Manhattan, New York City

- No personal or family history of Type 1, Type 2 or Gestational Diabetes

- BMI between ~24-42

Exclusion Criteria:

- Active cancer, unstable angina, recent stroke.

- Current therapy with medications that may affect glucose metabolism such as
glucocorticoids, adrenergic agents, etc.

- Evidence of a medical condition that might alter results or compromise the
elimination of the peptide, including active infection, kidney failure, severe liver
dysfunction, severe respiratory or cardiac failure

- Pregnancy: A pregnancy test will be done prior to enrollment and to each procedure in
all premenopausal women.
We found this trial at
1
site
New York, New York 10025
Principal Investigator: Blandine Laferrere, MD
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mi
from
New York, NY
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