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Completed

NCT Number: NCT02336659

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

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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Key information

Conditions

Severe Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exendin 9-39

Drug

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

Other names: GLP-1 antagonist

Sitagliptin

Drug

DPP-4 Inhibition

Other names: Januvia

Placebo

Other

Saline

Primary outcomes

  1. Ad libitum food intake (changes in food intake)

    Time frame: 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 outcomes

  1. Glucose metabolism (iAUC of glucose and c-pep after a meal)

    Time frame: 3-12 month after RYGB

    Evaluated by iAUC of glucose and c-pep after a meal

  2. Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)

    Time frame: 3-12 month after RYGB

    Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal

  3. Appetite measurement (VAS-scores)

    Time frame: 3-12 month after RYGB

    Evaluated by VAS-scores

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2015
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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