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
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|
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
- Volumetric Changes of the Pancreas [ Time Frame: 6 weeks ]Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology
- Changes in Plasma Concentrations of Pancreatic Amylase and Lipase [ Time Frame: 6 weeks ]
- Changes in body weight [ Time Frame: 6 weeks ]
- Changes in glycemic index [ Time Frame: 6 weeks ]
- Plasma concentrations of glucagon, insulin and citrullin [ Time Frame: 6 weeks ]
- Plasma concentrations of the drug [ Time Frame: 6 weeks ]
- Other MR based changes in the pancreas (edema, cellularity and structural changes) [ Time Frame: 6 weeks ]
- Uptake of fluorothymidine tracer in the pancreas measured by PET [ Time Frame: 6 weeks ]
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
|Contact: Nicolai Albrechtsen, MD, PhDfirstname.lastname@example.org|
|Contact: Jens Holst, MD, DMSci||+45 28 75 75 email@example.com|
|Department of Endocrinology||Recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Sten Madsbad, MD, DMSci 38622291 Sten.Madsbad@regionh.dk|
|Contact: Maria Svane, MD 38626357 firstname.lastname@example.org|