Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
1 other identifier
interventional
12
1 country
1
Brief Summary
The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Typical duration for not_applicable
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
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 21, 2016
June 1, 2016
2.1 years
January 8, 2015
June 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Ad libitum food intake (changes in food intake)
Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor
3-12 month after RYGB
Secondary Outcomes (3)
Glucose metabolism (iAUC of glucose and c-pep after a meal)
3-12 month after RYGB
Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
3-12 month after RYGB
Appetite measurement (VAS-scores)
3-12 month after RYGB
Study Arms (4)
Saline
PLACEBO COMPARATORMixed meal test and ad libitum meal test duing infusion of saline
Exendin 9-39
EXPERIMENTALMixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min
DPP-4 Inhibition
EXPERIMENTALMixed meal test and ad libitum meal test during intake of sitagliptin 100 mg \* 2
Exendin 9-39 / DPP 4-Inhibition
EXPERIMENTALMixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg \* 2
Interventions
Exendin 9-39 is a specific GLP-1 receptor antagonist
DPP-4 Inhibition
Eligibility Criteria
You may qualify if:
- Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose \<7.0 mM and HbA1c \< 48 mmol/mol 3 month after RYGB.
You may not qualify if:
- Fasting plasma glucose \>7.0 mM and HbA1c \> 48 mmol/mol 3 month after RYGB. Hemoglobin \<6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
- Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- University of Copenhagencollaborator
Study Sites (1)
Hvidovre University Hospital
Hvidovre, DK-2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sten Madbad, MD, DMSc
Hvidovre University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 8, 2015
First Posted
January 13, 2015
Study Start
April 1, 2014
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06