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

Obesity Clinical Trial

— i-LAB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02718950
• Other study ID #: i-LAB
• Secondary ID: U1111-1178-4180
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 18, 2016
• Last updated: March 23, 2016
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: March 2016
• Source: University of Campinas, Brazil
• Contact: Bruno Geloneze, MD, PhD
• Phone: +55 19 35218589
• Email: bgeloneze[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Liraglutide 3.0 mg
Subjects will use liraglutide 3.0 mg for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans	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	2 weeks	No
Secondary	Evaluate the effect of liraglutide administration on hypothalamic activation in humans	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	2 weeks	No
Secondary	Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans	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	2 weeks	No
Secondary	Evaluate the effect of liraglutide administration on body weight in humans	Evaluate the effect of liraglutide administration on total body weight (kg) in humans prior and after 2 weeks on liraglutide 3.0 mg	2 weeks	No
Secondary	Evaluate the effect of liraglutide administration on metabolic basal rate in humans	Evaluate the effect of liraglutide administration on basal kilocalories/day in humans prior and after 2 weeks on liraglutide 3.0 mg	2 weeks	No
Secondary	Evaluate the effect of liraglutide administration on body composition in humans	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	2 weeks	No