The Effect of Liraglutide on Pancreatic Hormones and Its Size

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Liraglutide on Pancreatic Hormones and Its Size

Conditions
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Obesity

Intervention / Treatment
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* Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 Receptor Agonist (Liraglutide)<br>3.0mg daily dose | Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml<br>* Treatment with Liraglutide (3.0mg per day) for  6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric Changes of the Pancreas | Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Plasma Concentrations of Pancreatic Amylase and Lipase |  | 6 weeks | 
| Changes in body weight |  | 6 weeks | 
| Changes in glycemic index |  | 6 weeks | 
| Plasma concentrations of glucagon, insulin and citrullin |  | 6 weeks | 
| Plasma concentrations of the drug |  | 6 weeks | 
| Other MR based changes in the pancreas (edema, cellularity and structural changes) |  | 6 weeks | 
| Uptake of fluorothymidine tracer in the pancreas measured by PET |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipase, Amylase, GLP-1