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Determinants of Diabetes Remission After Gastric Bypass Surgery

Sponsor
Blandine Laferrere (Other)
Overall Status
Completed
CT.gov ID
NCT02287285
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
25
Enrollment
1
Location
1
Arm
57
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1).

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in 30-40% body weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight loss, suggesting that the nature of the procedure, rather than the weight loss, is responsible for the T2DM improvement. Recent data have singled out the role of the gut hormones known as incretins in diabetes improvement after GBP. The current proposal will study 1) whether the short and long term change in the gut hormone incretins after GBP results in improved insulin secretion in response to the administration of oral and IV glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to define better surgical outcome on diabetes.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long Term Change of GLP-1 Insulinotropic Effect After GBP Surgery
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exendin9

Longitudinal study of insulin secretion and sensitivity in patients with type 2 diabetes before and after gastric bypass surgery.

Drug: Exendin9
Dosed at 600 pmol/kg/min for 210 minutes.
Other Names:
  • Exendin(9-39)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Beta Cell Sensitivity (BCS) [at 2 years post GBP surgery]

      Oral glucose tolerance test (OGTT) will be used to calculate BCS Graded glucose infusion with arginine (GGI) will be used to calculate BCS

    Secondary Outcome Measures

    1. Insulin Secretion Rate (ISR) after OGTT [2 years post GBP surgery]

      An oral glucose tolerance test (OGTT) will be used to estimate ISR in subjects before and up to 2 years after GBP

    2. Insulin Secretion Rate (ISR) after GGI [2 years post GBP surgery]

      A graded glucose infusion with arginine (GGI) will be used to estimate ISR in subjects before and up to 2 years after GBP

    3. Maximal Beta Cell Function [2 years post GBP surgery]

      The effect of a graded glucose infusion with arginine (GGI) on insulin secretion rate (ISR) will be measured in subjects before and up to 2 years after GBP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery

    • Blood pressure is under at least moderate control <160/100 mmHg

    • Patients can be on dyslipidemia medications but need fasting triglyceride < 600 mg/dl

    • Patients without recent (last 6 months) history of cardiovascular disease (CVD)

    • BMI > 35 and < 55 kg/m2 prior to GBP surgery

    Exclusion Criteria:

    • Active cancer

    • Unstable angina

    • Recent stroke

    • Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc

    • Active infection

    • Kidney failure

    • Severe liver dysfunction

    • Severe respiratory or cardiac failure

    • History of allergic reaction to exendin 9-39

    • History of pancreatitis, history of cholelithiasis, history of alcoholism

    • Presence of high triglyceride levels (>600 ng/dl)

    • Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York Obesity Research Center, Columbia University New York New York United States 10032

    Sponsors and Collaborators

    • Blandine Laferrere
    • National Institutes of Health (NIH)
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Blandine Laferrere, MD, New York Obesity Nutrition Research Center, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Blandine Laferrere, Professor of Medicine, Columbia University, Columbia University
    ClinicalTrials.gov Identifier:
    NCT02287285
    Other Study ID Numbers:
    • AAAO1360
    • 1R01DK098056-01A1
    • 1F32DK113747-01A1
    First Posted:
    Nov 10, 2014
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Blandine Laferrere, Professor of Medicine, Columbia University, Columbia University
    Type 2 Diabetes Mellitus
    Gastric Bypass Surgery
    Exendin9
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Apr 24, 2020