ObesityPhase 3i-LABNCT02718950
Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
A Phase 3 study testing Liraglutide 3.0 mg in people with Obesity and Type 2 Diabetes Mellitus, run by University of Campinas, Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Liraglutide 3.0 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index over 30 kg/m2.
Who cannot join
- 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;
Show all 25Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Liraglutide 3.0 mg
- Keywords
- Brown Adipose Tissue, Hypothalamic Activation, Non-shivering Thermogenesis, Basal Metabolic Rate, Liraglutide, Victoza, Body Composition, Body weight, Adipose Tissue Biopsy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 3.0 mgDrug
Also called Victoza
Subjects will use liraglutide 3.0 mg for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | Subjects will use liraglutide 3.0 mg for 2 weeks. Receives: Drug: Liraglutide 3.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (5)
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
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: 2 weeks
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Geloneze, University of Campinas, Brazil
- Investigators
- Bruno Geloneze, MD, PhD, Principal investigator, University of CampinasLício A Velloso, MD, PhD, Principal investigator, University of CampinasJosé C Lima Júnior, MD, Study chair, University of CampinasRiobaldo M Cintra, MD, Study chair, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718950
- Sponsor's protocol ID
- i-LAB
- Other IDs
- U1111-1178-4180
- Acronym
- i-LAB
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
- ClinicalTrials.gov ID
- NCT02718950
- Acronym / sponsor ID
- i-LAB / i-LAB
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Brown Adipose Tissue, Hypothalamic Activation, Non-shivering Thermogenesis, Basal Metabolic Rate, Liraglutide, Victoza, Body Composition, Body weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | Drug: Liraglutide 3.0 mgSubjects will use liraglutide 3.0 mg for 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index over 30 kg/m2.
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide 3.0 mgAlso: VictozaSubjects will use liraglutide 3.0 mg for 2 weeks | Drug | Liraglutide 3.0 mg |
Primary outcome
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
5 secondary outcomes
Evaluate the effect of liraglutide administration on hypothalamic activation in humans
Time frame: 2 weeks
Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans
Time frame: 2 weeks
Evaluate the effect of liraglutide administration on body weight in humans
Time frame: 2 weeks
Evaluate the effect of liraglutide administration on metabolic basal rate in humans
Time frame: 2 weeks
Evaluate the effect of liraglutide administration on body composition in humans
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Geloneze, MD, PhD principal investigator
University of Campinas
Lício A Velloso, MD, PhD principal investigator
University of Campinas
José C Lima Júnior, MD study chair
University of Campinas
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide 3.0 mg in people with Obesity and Type 2 Diabetes Mellitus, run by University of Campinas, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Geloneze, MD, PhD (+55 19 35218589, bgeloneze@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.