Clinical trial NCT03520062: The Effect of Liraglutide on Pancreatic Hormones and Its Size
Official title: The Effect of Liraglutide on Pancreatic Hormones and Its Size
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Amylase
Lipase
GLP-1
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Rigshospitalet, Denmark
First posted: 2018-05-09
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Volumetric Changes of the Pancreas
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in Plasma Concentrations of Pancreatic Amylase and Lipase
timeFrame: 6 weeks
measure: Changes in body weight
timeFrame: 6 weeks
measure: Changes in glycemic index
timeFrame: 6 weeks
measure: Plasma concentrations of glucagon, insulin and citrullin
timeFrame: 6 weeks
measure: Plasma concentrations of the drug
timeFrame: 6 weeks
measure: Other MR based changes in the pancreas (edema, cellularity and structural changes)
timeFrame: 6 weeks
measure: Uptake of fluorothymidine tracer in the pancreas measured by PET
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology
Study officials:
References: