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Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI

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ClinicalTrials.gov Identifier: NCT01562678
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Conditions Diabetes
Effects of Liraglutide Administration on Brain Activity
Weight Loss
Hunger
Interventions Drug: Liraglutide
Drug: Placebo
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liraglutide First, Then Placebo Placebo First, Then Liraglutide
Hide Arm/Group Description 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
Period Title: Overall Study
Started 14 14
Completed 8 12
Not Completed 6 2
Arm/Group Title Liraglutide First, Then Placebo Placebo First, Then Liraglutide Total
Hide Arm/Group Description 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
52.5  (10.5) 52.5  (10.5) 52.5  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
5
  35.7%
12
  42.9%
Male
7
  50.0%
9
  64.3%
16
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization
Hide Description Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.
Time Frame 18 days of Liraglutide or placebo treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with incomplete MRI scans were excluded from the analysis.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).
Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
Overall Number of Participants Analyzed 18 18
Mean (Standard Error)
Unit of Measure: z-scores of activation in cortex
-0.42  (0.27) 0.53  (0.37)
Time Frame Throughout the study (4 visits in each phase of liraglutide and placebo).
Adverse Event Reporting Description There was a systematic assessment of adverse events at each visit (Days 0, 7, 14, and 17) by an MD who asked detailed medical questions and did a physical exam, plus through the use of visual analog scales administered 3 times per day where participants answered on a 10cm line questions such as "How nauseous do you feel right now?"
 
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
All-Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/28 (25.00%)      7/28 (25.00%)    
Gastrointestinal disorders     
Nausea   7/28 (25.00%)  7 7/28 (25.00%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christos Mantzoros
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667- 8630
EMail: cmantzor@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01562678     History of Changes
Other Study ID Numbers: 2011P000280
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: December 22, 2015
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017