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

Severe Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336659
• Other study ID #: MSV-14
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: June 20, 2016
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Drug:
• exendin 9-39
Exendin 9-39 is a specific GLP-1 receptor antagonist
• sitagliptin
DPP-4 Inhibition

Other:
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Glucose metabolism (iAUC of glucose and c-pep after a meal)	Evaluated by iAUC of glucose and c-pep after a meal	3-12 month after RYGB	No
Secondary	Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)	Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal	3-12 month after RYGB	No
Secondary	Appetite measurement (VAS-scores)	Evaluated by VAS-scores	3-12 month after RYGB	No