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Trial record 2 of 396 for:    LIRAGLUTIDE

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

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ClinicalTrials.gov Identifier: NCT02718950
Recruitment Status : Unknown
Verified March 2016 by Bruno Geloneze, University of Campinas, Brazil.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Bruno Geloneze, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Mellitus Drug: Liraglutide 3.0 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
Study Start Date : June 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide 3.0 mg
Subjects will use liraglutide 3.0 mg for 2 weeks.
Drug: Liraglutide 3.0 mg
Subjects will use liraglutide 3.0 mg for 2 weeks
Other Name: Victoza




Primary Outcome Measures :
  1. Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans [ Time Frame: 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 Outcome Measures :
  1. Evaluate the effect of liraglutide administration on hypothalamic activation in humans [ Time Frame: 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

  2. Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans [ Time Frame: 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

  3. Evaluate the effect of liraglutide administration on body weight in humans [ Time Frame: 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

  4. Evaluate the effect of liraglutide administration on metabolic basal rate in humans [ Time Frame: 2 weeks ]
    Evaluate the effect of liraglutide administration on basal kilocalories/day in humans prior and after 2 weeks on liraglutide 3.0 mg

  5. Evaluate the effect of liraglutide administration on body composition in humans [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718950


Contacts
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Contact: Bruno Geloneze, MD, PhD +55 19 35218589 bgeloneze@terra.com.br

Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Bruno Geloneze, MD, PhD University of Campinas
Principal Investigator: Lício A Velloso, MD, PhD University of Campinas
Study Chair: José C Lima Júnior, MD University of Campinas
Study Chair: Riobaldo M Cintra, MD University of Campinas

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Responsible Party: Bruno Geloneze, MD, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02718950     History of Changes
Other Study ID Numbers: i-LAB
U1111-1178-4180 ( Registry Identifier: Universal Trial Number )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bruno Geloneze, University of Campinas, Brazil:
Brown Adipose Tissue
Hypothalamic Activation
Non-shivering Thermogenesis
Basal Metabolic Rate
Liraglutide
Victoza
Body Composition
Body weight
Adipose Tissue Biopsy
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists