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

Primary Purpose

Severe Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
exendin 9-39
sitagliptin
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Severe Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Saline

Exendin 9-39

DPP-4 Inhibition

Exendin 9-39 / DPP 4-Inhibition

Arm Description

Mixed meal test and ad libitum meal test duing infusion of saline

Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min

Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glucose metabolism (iAUC of glucose and c-pep after a meal)
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)
Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal
Appetite measurement (VAS-scores)
Evaluated by VAS-scores

Full Information

First Posted
January 8, 2015
Last Updated
June 20, 2016
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02336659
Brief Title
Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Official Title
Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Mixed meal test and ad libitum meal test duing infusion of saline
Arm Title
Exendin 9-39
Arm Type
Experimental
Arm Description
Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min
Arm Title
DPP-4 Inhibition
Arm Type
Experimental
Arm Description
Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2
Arm Title
Exendin 9-39 / DPP 4-Inhibition
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
exendin 9-39
Other Intervention Name(s)
GLP-1 antagonist
Intervention Description
Exendin 9-39 is a specific GLP-1 receptor antagonist
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
DPP-4 Inhibition
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Ad libitum food intake (changes in food intake)
Description
Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor
Time Frame
3-12 month after RYGB
Secondary Outcome Measure Information:
Title
Glucose metabolism (iAUC of glucose and c-pep after a meal)
Description
Evaluated by iAUC of glucose and c-pep after a meal
Time Frame
3-12 month after RYGB
Title
Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
Description
Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal
Time Frame
3-12 month after RYGB
Title
Appetite measurement (VAS-scores)
Description
Evaluated by VAS-scores
Time Frame
3-12 month after RYGB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten Madbad, MD, DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark

12. IPD Sharing Statement

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

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