Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Brown Adipose Tissue, Hypothalamic Activation, Non-shivering Thermogenesis, Basal Metabolic Rate, Liraglutide, Victoza, Body Composition, Body weight, Adipose Tissue Biopsy
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.
Interventions
Subjects will use liraglutide 3.0 mg for 2 weeks
Sponsors
University of Campinas, Brazil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index over 30 kg/m2.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Contacts
Primary ContactBruno Geloneze, MD, PhD
Outcome results
None listed