Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02336659

Enrollment

Registered

2015-01-13

Start date

2014-04-30

Completion date

2016-06-30

Last updated

2016-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Obesity

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.

Detailed description

To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.

Interventions

DRUGexendin 9-39

Exendin 9-39 is a specific GLP-1 receptor antagonist

DRUGsitagliptin

DPP-4 Inhibition

OTHERPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame	Description
Ad libitum food intake (changes in food intake)	3-12 month after RYGB	Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor

Secondary

Measure	Time frame	Description
Glucose metabolism (iAUC of glucose and c-pep after a meal)	3-12 month after RYGB	Evaluated by iAUC of glucose and c-pep after a meal
Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)	3-12 month after RYGB	Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal
Appetite measurement (VAS-scores)	3-12 month after RYGB	Evaluated by VAS-scores

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026