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The Effect of Liraglutide on Pancreatic Hormones and Its Size (LIRAP)

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ClinicalTrials.gov Identifier: NCT03520062
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Hvidovre University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Nicolai Jacob Wewer Albrechtsen, University of Copenhagen

Brief Summary:

Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been found an increased risk of acute pancreatitis.

Animal and cell studies have shown that the increased levels of amylase and lipase in the blood are not due to an inflammatory state but adaptive changes (volume increase) of the pancreas.

The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate whether the increased levels of amylase and lipase in the blood of individuals treated with the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by measuring amylase and lipase before, during and after treatment with a GLP-1 receptor agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any volumetric changes in the pancreas with high reproducibility.

The scan will be centered on the pancreas, other organs are not evaluated why the study is not designed to detect any malignant findings in the pancreas or other organs.


Condition or disease Intervention/treatment Phase
Obesity Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Liraglutide on Pancreatic Hormones and Its Size
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 15, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: GLP-1 Receptor Agonist (Liraglutide)
3.0mg daily dose
Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Treatment with Liraglutide (3.0mg per day) for ~6 weeks




Primary Outcome Measures :
  1. Volumetric Changes of the Pancreas [ Time Frame: 6 weeks ]
    Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology


Secondary Outcome Measures :
  1. Changes in Plasma Concentrations of Pancreatic Amylase and Lipase [ Time Frame: 6 weeks ]
  2. Changes in body weight [ Time Frame: 6 weeks ]
  3. Changes in glycemic index [ Time Frame: 6 weeks ]
  4. Plasma concentrations of glucagon, insulin and citrullin [ Time Frame: 6 weeks ]
  5. Plasma concentrations of the drug [ Time Frame: 6 weeks ]
  6. Other MR based changes in the pancreas (edema, cellularity and structural changes) [ Time Frame: 6 weeks ]
  7. Uptake of fluorothymidine tracer in the pancreas measured by PET [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 26 og < 50 kg/m2

Exclusion Criteria:

  • Abdominal Diameter >60cm type 1 or type 2 diabetes Heart Failure or Disease Statins Kidney or Liver disease Thyroid Disease Inflammatory Bowel Disease Gastroparesis Cancer Lung disease Psychiatric disease Gastric Bypass operation Previous pancreatitis Increased alcoholic consumption Familiar incidence of multiple endocrine neoplasia Previous treatment with GLP-1 (incretin) based medicine Pacemaker or other non-MR-compatible devices

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): NCT03520062


Contacts
Contact: Nicolai Albrechtsen, MD, PhD +4529649329 hgk795@ku.dk
Contact: Jens Holst, MD, DMSci +45 28 75 75 18 jjholst@sund.ku.dk

Locations
Denmark
Department of Endocrinology Recruiting
Hvidovre, Denmark, 2650
Contact: Sten Madsbad, MD, DMSci    38622291    Sten.Madsbad@regionh.dk   
Contact: Maria Svane, MD    38626357    mariasvane@hotmail.com   
Sponsors and Collaborators
Nicolai Jacob Wewer Albrechtsen
Hvidovre University Hospital
Rigshospitalet, Denmark

Responsible Party: Nicolai Jacob Wewer Albrechtsen, Postdoc, MD, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03520062     History of Changes
Other Study ID Numbers: LIRAP
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have yet not decided to share IPD as this also would require approval from the ethical and data approval comite

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nicolai Jacob Wewer Albrechtsen, University of Copenhagen:
Amylase
Lipase
GLP-1

Additional relevant MeSH terms:
Hormones
Liraglutide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins