Clinical trial NCT02718950: Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
Official title: Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Brown Adipose Tissue
Hypothalamic Activation
Non-shivering Thermogenesis
Basal Metabolic Rate
Liraglutide
Victoza
Body Composition
Body weight
Adipose Tissue Biopsy
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluate the effect of liraglutide administration on hypothalamic activation in humans
timeFrame: 2 weeks
measure: Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans
timeFrame: 2 weeks
measure: Evaluate the effect of liraglutide administration on body weight in humans
timeFrame: 2 weeks
measure: Evaluate the effect of liraglutide administration on metabolic basal rate in humans
timeFrame: 2 weeks
measure: Evaluate the effect of liraglutide administration on body composition in humans
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Campinas
name: Bruno Geloneze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas
name: Lício A Velloso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas
name: José C Lima Júnior, MD
role: STUDY_CHAIR
affiliation: University of Campinas
name: Riobaldo M Cintra, MD
role: STUDY_CHAIR
References: