The Effect of Liraglutide on Pancreatic Hormones and Its Size

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

• Registration Number: NCT03520062
• Lead Sponsor: Nicolai Jacob Wewer Albrechtsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-15
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Primary Completion: 2019-04-30
• Study Completion: 2020-01-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLP-1 Receptor Agonist (Liraglutide)	Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml	3.0mg daily dose

Primary Outcome Measures

Name	Time	Method
Volumetric Changes of the Pancreas	6 weeks	Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology; 🇩🇰 Hvidovre, Denmark