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

NCT02718950 | Unknown Phase 3 DMC

• 2 other identifiers: i-LABU1111-1178-4180
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Evaluate the effect of liraglutide administration on hypothalamic activation in humans

  2 weeks

• Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans

  2 weeks

• Evaluate the effect of liraglutide administration on body weight in humans

  2 weeks

• Evaluate the effect of liraglutide administration on metabolic basal rate in humans

  2 weeks

• Evaluate the effect of liraglutide administration on body composition in humans

  2 weeks

Study Arms (1)

Liraglutide 3.0 mg

EXPERIMENTAL

Subjects will use liraglutide 3.0 mg for 2 weeks.

Drug: Liraglutide 3.0 mg

Interventions

Liraglutide 3.0 mg DRUG

Subjects will use liraglutide 3.0 mg for 2 weeks

Also known as: Victoza

Liraglutide 3.0 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index over 30 kg/m2.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Body Weight

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bruno Geloneze, MD, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

• Lício A Velloso, MD, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

• José C Lima Júnior, MD

  University of Campinas

  STUDY CHAIR

• Riobaldo M Cintra, MD

  University of Campinas

  STUDY CHAIR

Central Study Contacts

Bruno Geloneze, MD, PhD

CONTACT

+55 19 35218589; bgeloneze@terra.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 24, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 24, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share