GLP1-imaging Before and After Bariatric Surgery
Visualizing Beta Cells in Patients With T2D Before and After Bariatric Surgery
1 other identifier
interventional
12
1 country
2
Brief Summary
In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data will provide investigators with more information on the contribution of the beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the prognostic value of pre-operative beta cell mass determination to T2D resolution. This might be of great interest for the assessment of RYGB as an alternative therapy in patients with T2D and a BMI \<35, who currently do not meet the international guidelines for bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Oct 2016
Longer than P75 for phase_1 diabetes-mellitus-type-2
2 active sites
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 7, 2016
CompletedFirst Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJune 21, 2022
June 1, 2021
6.7 years
May 29, 2017
June 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pancreatic uptake of 68Ga-NODAGA-exendin-4
Change in tracer uptake before and after RYGB
4 years
Secondary Outcomes (2)
T2D outcome
after 1 year
Beta cell function
4 years
Study Arms (1)
RYGB patients
EXPERIMENTALPatients who will receive a RYGB surgery
Interventions
Eligibility Criteria
You may qualify if:
- Morbid obese T2D patient who will have RYGB at the Rijnstate in Arnhem
- Female
- Signed informed consent
- Mild T2D:
- C-peptide \> 1.0 nmol/L
- Only metformin usage as anti-diabetic medication
- Progressive T2D:
- C-peptide \< 1.0 nmol/L
- Insulin and/or sulfonylurea (SU) usage
You may not qualify if:
- Fasting glucose \< 6 at time C-peptide was determined
- Liver failure
- BMI \> 50 kg/m-2
- Previous treatment with synthetic exendin
- Pregnancy
- Breast feeding
- Kidney failure
- Age \< 18 years
- No signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Rijnstate Hospitalcollaborator
Study Sites (2)
Rijnstate hospital
Arnhem, Netherlands
Radboudumc
Nijmegen, 6500HB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 9, 2017
Study Start
October 7, 2016
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
June 21, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share