The Effect of Liraglutide on Pancreatic Hormones and Its Size

Obesity Clinical Trial

— LIRAP  

Official title:

The Effect of Liraglutide on Pancreatic Hormones and Its Size

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520062
• Other study ID #: LIRAP
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 1, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Treatment with Liraglutide (3.0mg per day) for ~6 weeks

Locations

Country	Name	City	State
Denmark	Department of Endocrinology	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Nicolai Jacob Wewer Albrechtsen	Hvidovre University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric Changes of the Pancreas	Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology	6 weeks
Secondary	Changes in Plasma Concentrations of Pancreatic Amylase and Lipase		6 weeks
Secondary	Changes in body weight		6 weeks
Secondary	Changes in glycemic index		6 weeks
Secondary	Plasma concentrations of glucagon, insulin and citrullin		6 weeks
Secondary	Plasma concentrations of the drug		6 weeks
Secondary	Other MR based changes in the pancreas (edema, cellularity and structural changes)		6 weeks
Secondary	Uptake of fluorothymidine tracer in the pancreas measured by PET		4 weeks