Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans (i-LAB)

University of Campinas, Brazil

Status and phase

Unknown

Phase 3

Conditions

Type 2 Diabetes Mellitus

Obesity

Treatments

Drug: Liraglutide 3.0 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02718950

U1111-1178-4180 (Registry Identifier)

i-LAB

Details and patient eligibility

About

The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.