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Completed

NCT Number: NCT03520062

The Effect of Liraglutide on Pancreatic Hormones and Its Size

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Volumetric Changes of the Pancreas

    Time frame: 6 weeks

    Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology

Secondary outcomes

  1. Changes in Plasma Concentrations of Pancreatic Amylase and Lipase

    Time frame: 6 weeks

  2. Changes in body weight

    Time frame: 6 weeks

  3. Changes in glycemic index

    Time frame: 6 weeks

  4. Plasma concentrations of glucagon, insulin and citrullin

    Time frame: 6 weeks

  5. Plasma concentrations of the drug

    Time frame: 6 weeks

  6. Other MR based changes in the pancreas (edema, cellularity and structural changes)

    Time frame: 6 weeks

  7. Uptake of fluorothymidine tracer in the pancreas measured by PET

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Nicolai Jacob Wewer Albrechtsen

Other

Collaborators

  • Hvidovre University Hospital
  • Rigshospitalet, Denmark

Registry information

Acronym: LIRAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 9, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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