The Effect of Liraglutide on Pancreatic Hormones and Its Size

NCT ID: NCT03520062

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2020-01-01

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

GLP-1 Receptor Agonist (Liraglutide)

3.0mg daily dose

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Treatment with Liraglutide (3.0mg per day) for \~6 weeks

Interventions

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

Treatment with Liraglutide (3.0mg per day) for \~6 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Nicolai Jacob Wewer Albrechtsen

OTHER

Sponsor Role: lead

Responsible Party

Nicolai Jacob Wewer Albrechtsen

Postdoc, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Endocrinology

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

LIRAP

Identifier Type: -

Identifier Source: org_study_id