Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
- Registration Number
- NCT02718950
- Lead Sponsor
- University of Campinas, Brazil
- Brief Summary
The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Body mass index over 30 kg/m2.
- Hypersensitivity to liraglutide or any of its vehicle components;
- History of diabetes or pre-diabetes - either by fasting glycemia, oGTT or HbA1c;
- Previous treatment within the last 3 months with glucagon like peptide-1 agonists, iDPP4 or any medication that is associated with BAT activation, including propranolol and benzodiazepines;
- Liver diseases, except non-alcoholic steatohepatitis (NASH);
- Infection by HIV, hepatitis B or hepatitis C;
- Addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine;
- Obesity induced by other disorders such as Cushing syndrome, hypothyroidism, lipodystrophy
- Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);
- Current participation (or within the last 3 months) in an organized weight reduction program
- Currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial)
- Participation in a clinical trial within the last 3 months prior to screening
- Simultaneous participation in any other clinical trial of an investigational drug
- Previous surgical treatment of obesity;
- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial
- Liver enzyme (ALT and AST) above 2.5 x of reference range
- Pancreatic enzymes (amylase, lipase) above 3 x the reference range
- Chronic kidney disease stages 3, 4, or 5
- Relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator
- Any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety
- Blood donation or transfusion within the last 3 months
- Pregnancy or intention of pregnancy
- History of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
- History of pancreatitis
- Less than 80% of liraglutide adherence
- Calcitonin above the reference range at the screening visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liraglutide 3.0 mg Liraglutide 3.0 mg Subjects will use liraglutide 3.0 mg for 2 weeks.
- Primary Outcome Measures
Name Time Method Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans 2 weeks Activation of BAT, as considered Standard Uptake Value (SUV) threshold of 2.0 on 18-FDG-PET CT, prior to liraglutide use and after 2 weeks on liraglutide 3.0 mg
- Secondary Outcome Measures
Name Time Method Evaluate the effect of liraglutide administration on hypothalamic activation in humans 2 weeks Evaluate the effect of liraglutide administration on hypothalamic tract activation as assessed by magnetic resonance image in humans prior and after 2 weeks on liraglutide 3.0 mg
Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans 2 weeks Evaluate the effect of liraglutide administration on non-shivering thermogenesis by infrared thermography and indirect calorimetry in humans prior and after 2 weeks on liraglutide 3.0 mg
Evaluate the effect of liraglutide administration on body weight in humans 2 weeks Evaluate the effect of liraglutide administration on total body weight (kg) in humans prior and after 2 weeks on liraglutide 3.0 mg
Evaluate the effect of liraglutide administration on metabolic basal rate in humans 2 weeks Evaluate the effect of liraglutide administration on basal kilocalories/day in humans prior and after 2 weeks on liraglutide 3.0 mg
Evaluate the effect of liraglutide administration on body composition in humans 2 weeks Evaluate the effect of liraglutide administration on lean mass and fat percentage as assessed by dual x-ray absorptiometry (DXA) in humans prior and after 2 weeks on liraglutide 3.0 mg