The aim of the study is to investigate if liraglutide (Saxenda) increases plasma levels of the two pancreatic enzymes: amylase and lipase, in overweight non-diabetic subjects, and to correlate such changes with changes of the pancreas (volumen estimated by PET-MR) MedDRA version: 20.0 Level: LLT Classification code 10053880 Term: Blood pancreatic amylase increased System Organ Class: 100000004848 M
Conditions
Interventions
Trade Name: Saxenda
Product Name: Saxenda
Product Code: SUB25238
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or
Sponsors
University of Copenhagen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: BMI higher or equal 26 and less than 50 kg/m2 Age over or equal 18 and under 65 years Men Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Abdominal waist over 60cm type 1 or type 2 diabetes Angina Pectoris, Heart Failure Statin treatment Kidney or liver disease Thyroid disease Inflammatory Bowel Disease Known Gastroparesis Cancer Obstructive or Restrictive lungdisease Psychiatric disease Previous gastric bypass operated Previously or currently acute pancreatitis Alchohol comsumption over the recommended amount by the authorities (Sundhedsstyrrelsen) Multiple Endocrine Neoplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if liraglutide increases the volumen of the pancreas and as a consequence increases plasma levels of amylase and lipase;Secondary Objective: Not applicable;Primary end point(s): volumen (mL) of the pancreas determinted by magnet resonance ;Timepoint(s) of evaluation of this end point: Determined twice during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma concentrations of amylase and lipase weight changes Changes in glycemic control Plasma levels of glucagon, insulin and citrullin Levels of liraglutide Other imaging abnormalities in the pancreas flour-deoxyglucose uptake in the pancreas ;Timepoint(s) of evaluation of this end point: Two times during the study, for the plasma levels three times | — |
Countries
Denmark
Contacts
Public ContactNicolai Jacob Wewer Albrechtsen
University of Copenhagen
Outcome results
None listed