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Trial record 23 of 395 for:    PYY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02336659
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Maria Saur Svane, 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.

Condition or disease Intervention/treatment Phase
Severe Obesity Drug: exendin 9-39 Drug: sitagliptin Other: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Study Start Date : April 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Placebo Comparator: Saline
Mixed meal test and ad libitum meal test duing infusion of saline
Other: Placebo
Saline

Experimental: Exendin 9-39
Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min
Drug: exendin 9-39
Exendin 9-39 is a specific GLP-1 receptor antagonist
Other Name: GLP-1 antagonist

Experimental: DPP-4 Inhibition
Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2
Drug: sitagliptin
DPP-4 Inhibition
Other Name: Januvia

Experimental: 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
Drug: exendin 9-39
Exendin 9-39 is a specific GLP-1 receptor antagonist
Other Name: GLP-1 antagonist

Drug: sitagliptin
DPP-4 Inhibition
Other Name: Januvia




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336659


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Investigators
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Study Chair: Sten Madbad, MD, DMSc Hvidovre University Hospital

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Responsible Party: Maria Saur Svane, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02336659     History of Changes
Other Study ID Numbers: MSV-14
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Sitagliptin Phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action