NCT03520062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

April 24, 2018

Last Update Submit

March 23, 2020

Conditions

Obesity

Keywords

AmylaseLipaseGLP-1

Outcome Measures

Primary Outcomes (1)

  • Volumetric Changes of the Pancreas

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

    6 weeks

Secondary Outcomes (7)

  • Changes in Plasma Concentrations of Pancreatic Amylase and Lipase

    6 weeks

  • Changes in body weight

    6 weeks

  • Changes in glycemic index

    6 weeks

  • Plasma concentrations of glucagon, insulin and citrullin

    6 weeks

  • Plasma concentrations of the drug

    6 weeks

  • +2 more secondary outcomes

Study Arms (1)

GLP-1 Receptor Agonist (Liraglutide)

EXPERIMENTAL

3.0mg daily dose

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

Interventions

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

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

GLP-1 Receptor Agonist (Liraglutide)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 26 og \< 50 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoc, MD, PhD

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 9, 2018

Study Start

August 15, 2017

Primary Completion

April 30, 2019

Study Completion

January 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

DK(1)