Determinants of Diabetes Remission After Gastric Bypass Surgery
Long Term Change of GLP-1 Insulinotropic Effect After GBP Surgery
3 other identifiers
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 type-2-diabetes-mellitus
Started Oct 2014
Longer than P75 for early_phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedApril 24, 2020
April 1, 2020
2.8 years
October 10, 2014
April 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beta Cell Sensitivity (BCS)
Oral glucose tolerance test (OGTT) will be used to calculate BCS Graded glucose infusion with arginine (GGI) will be used to calculate BCS
at 2 years post GBP surgery
Secondary Outcomes (3)
Insulin Secretion Rate (ISR) after OGTT
2 years post GBP surgery
Insulin Secretion Rate (ISR) after GGI
2 years post GBP surgery
Maximal Beta Cell Function
2 years post GBP surgery
Study Arms (1)
Exendin9
EXPERIMENTALLongitudinal study of insulin secretion and sensitivity in patients with type 2 diabetes before and after gastric bypass surgery.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Obesity Research Center, Columbia University
New York, New York, 10032, United States
Related Publications (2)
Prasad M, Mark V, Ligon C, Dutia R, Nair N, Shah A, Laferrere B. Role of the Gut in the Temporal Changes of beta-Cell Function After Gastric Bypass in Individuals With and Without Diabetes Remission. Diabetes Care. 2022 Feb 1;45(2):469-476. doi: 10.2337/dc21-1270.
PMID: 34857533DERIVEDShah A, Holter MM, Rimawi F, Mark V, Dutia R, McGinty J, Levin B, Laferrere B. Insulin Clearance After Oral and Intravenous Glucose Following Gastric Bypass and Gastric Banding Weight Loss. Diabetes Care. 2019 Feb;42(2):311-317. doi: 10.2337/dc18-1036. Epub 2018 Dec 6.
PMID: 30523032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Blandine Laferrere, MD
New York Obesity Nutrition Research Center, Columbia University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine, Columbia University
Study Record Dates
First Submitted
October 10, 2014
First Posted
November 10, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2017
Study Completion
July 1, 2019
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Wherever applicable, fully de-identified data will be deposited to appropriate public repositories, following the Federal Health Insurance Privacy and Portability Act (HIPAA). This will occur no longer than 6 months after publications of the data generated by this record, or, 18 months after completion of the funding period, should no data had been published..
- Access Criteria
- contact the PI
The data generated from this study will be presented at national or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this study will be submitted upon acceptance for publication to the digital archive NIH National Library of Medicine PubMed Central (PMC) database, according to the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research. Any data released for publication will be for research purposes only and will not include identifiable data on any of the participants.