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
The main purpose of this study is to help us understand the effects of diabetes medication Liraglutide on weight loss and hunger. The investigators have already determined what the highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide was approved by the FDA in January 2010 for treatment of diabetes.
The investigators will also study the following:
- The impact of Liraglutide on brain responses to food
- It's effect on physiological and mental performance
- If its effect on the brain differs among obese and lean diabetic subjects.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Effects of Liraglutide Administration on Brain Activity Weight Loss Hunger||Drug: Liraglutide Drug: Placebo||Phase 4|
This is a randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide on brain activation in areas involved in cognitive control and reward during food visualization.
Study participation will span approximately 1.5-2 months. Subjects will learn to self-administer the medication and will have a total of 8 study visits plus one screening visit. The visits will include the following tests/procedures:
- Vital signs (blood pressure, temperature, heart rate, breathing rate)
- Height, weight and other body measurements like waist
- Blood tests
- Urine pregnancy test (women only)
- Electrocardiogram (EKG)
- Medical history
- Physical exam
- Body Composition tests
- Study logs to record food intake and blood sugar
- functional MRI
We plan to recruit a total of 24 subjects to be treated with placebo and liraglutide. We propose to enroll 12 obese diabetic (type 2) and 12 lean diabetic (type 2) subjects. Equal numbers of men and women will be enrolled and the randomization will block for gender.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
In the experimental arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject Liraglutide once per day for 18 days. Subjects will start 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.
Other Name: victoza
|Placebo Comparator: Placebo||
In the placebo arm 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.
- Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization [ Time Frame: 18 days of Liraglutide or placebo treatment ]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.
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): NCT01562678
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christos Mantzoros, MD||Beth Israel Deaconess Medical Center|