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

Not Applicable

Completed

• Conditions: Severe Obesity
• Interventions: Other: Placebo; Drug: sitagliptin; Drug: exendin 9-39

• Registration Number: NCT02336659
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Mixed meal test and ad libitum meal test duing infusion of saline
DPP-4 Inhibition	sitagliptin	Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg \* 2
Exendin 9-39	exendin 9-39	Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min
Exendin 9-39 / DPP 4-Inhibition	exendin 9-39	Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg \* 2
Exendin 9-39 / DPP 4-Inhibition	sitagliptin	Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg \* 2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark