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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Severe Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Saline

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Exendin 9-39

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

Group Type EXPERIMENTAL

exendin 9-39

Intervention Type DRUG

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

DPP-4 Inhibition

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

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

DPP-4 Inhibition

Exendin 9-39 / DPP 4-Inhibition

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

Group Type EXPERIMENTAL

exendin 9-39

Intervention Type DRUG

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

sitagliptin

Intervention Type DRUG

DPP-4 Inhibition

Interventions

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exendin 9-39

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

Intervention Type DRUG

sitagliptin

DPP-4 Inhibition

Intervention Type DRUG

Placebo

Saline

Intervention Type OTHER

Other Intervention Names

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GLP-1 antagonist Januvia

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No