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

Nicolai Jacob Wewer Albrechtsen

Status: Completed

Conditions: Obesity

Treatments: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT03520062

LIRAP

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

GLP-1 Receptor Agonist (Liraglutide)

Experimental group

Description:

3.0mg daily dose

Treatment:

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