Splanchnic Blood Redistribution After Incretin Hormone Infusion and Obesity Surgery
GIP-PET
The Effects of Glucose-dependent Insulinotrophic Peptide (GIP) and Glucagon-like Peptide 1 (GLP-1) on Splanchnic Redistribution of Blood Flow at Postprandial State and After Roux-en-Y Gastric Bypass and Sleeve
1 other identifier
interventional
36
1 country
1
Brief Summary
Obesity is a worldwide problem and leads to multiple metabolic and endocrinological problems. Bariatric surgeries are a growing field as a treatment choice for morbid obesity (BMI \> 35 kg/m2). Clinical and research evidence shows that shortly after RYGB, T2DM resolves with improving glucose tolerance. Foregut hypothesis behind bariatric surgeries postulate, that bypassed portions of intestine contain a substance, that acts as an anti-incretin, ie. to counteract metabolically favourable incretins. In view of the recent studies, it may be that GIP is really the anti-incretin behind this hypothesis. The current study is conducted to investigate the vasoactive roles of the GIP. The investigators aim to show that GIP is the major contributor to the blood flow and tissue blood volume observed in postprandial state.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Jan 2013
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedOctober 20, 2021
October 1, 2021
2.8 years
February 25, 2013
October 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Splanchnic blood flow
Flow is measured using radiowater H2O and PET
24 months
Secondary Outcomes (1)
GIP and GLP-1 blood concetrations
24 months
Study Arms (3)
Royx-en-Y surgery
ACTIVE COMPARATORMixed meal test (MMS) with flow studies before and 2 months after the operation
Control
ACTIVE COMPARATORHealthy volunteer group, GIP, GLP-1 and MMS studies
Sleeve gastrectomy
EXPERIMENTALMixed meal test (MMS) with flow studies before and 2 months after the operation
Interventions
Subjects in the intervention group will be divided into two consecutive surgical groups, RYGB or SG. After the surgery, subjects are controlled in hospital ward for approximately three days.
Eligibility Criteria
You may qualify if:
- BMI \> 35 kg/m2
- Type 2 diabetes mellitus (fasting glucose more than 7 mmol/l)
- Age: 18-60 years
- Previous, carefully planned, conservative treatments for obesity have failed
You may not qualify if:
- BMI over 60 kg/m2
- Weight more than 170 kg
- Waist circumference \> 150 cm
- Insulin treatment requiring type 2 diabetes mellitus
- Mental disorder or poor compliance
- Eating disorder or excessive use of alcohol
- Active ulcus-disease
- Pregnancy
- Past dose of radiation
- Presence of any ferromagnetic objects that would make MR imaging contraindicated
- Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
- BMI 18-27 kg/m2
- Age 18-60 years
- Fasting plasma glucose less than 6.1 mmol/l
- Normal glucose tolerance test (OGTT)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Lund Universitycollaborator
Study Sites (1)
Turku univercity hospital, PET center
Turku, 20540, Finland
Related Publications (2)
Saari T, Koffert J, Honka H, Kauhanen S, U-Din M, Wierup N, Lindqvist A, Groop L, Virtanen KA, Nuutila P. Obesity-associated Blunted Subcutaneous Adipose Tissue Blood Flow After Meal Improves After Bariatric Surgery. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1930-1938. doi: 10.1210/clinem/dgac191.
PMID: 35363252DERIVEDHonka H, Koffert J, Kauhanen S, Teuho J, Hurme S, Mari A, Lindqvist A, Wierup N, Groop L, Nuutila P. Bariatric Surgery Enhances Splanchnic Vascular Responses in Patients With Type 2 Diabetes. Diabetes. 2017 Apr;66(4):880-885. doi: 10.2337/db16-0762. Epub 2017 Jan 17.
PMID: 28096259DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pirjo Nuutila, Prof
PET centre, Turku
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2013
First Posted
June 19, 2013
Study Start
January 1, 2013
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share