The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.
Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .
Texas Tech Neuroimaging Institute
Lubbock, Texas, United States
Nutrition & Metabolic Health Initiative
Lubbock, Texas, United States
Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Pre-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
Post-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group
Energy intake will be assessed via ad libitum feeding
Time frame: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation is paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Time frame: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via Peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be assessed via ghrelin
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss in Liraglutide 3.0 group by examine early change in pre-prandial fMRI-FCR
Pre-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss in Liraglutide 3.0 group by examine early change in post-prandial fMRI-FCR
Post-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in energy intake
Post-prandial fMRI-FCR measured via fMRI. Energy intake will be assessed via ad libitum feeding.
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1).
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via peptide YY (PYY).
Time frame: Baseline, Week 4, and Week 16
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via ghrelin.
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group
Energy intake will be assessed via ad libitum feeding.
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 11 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
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Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 12 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 13 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Examine if the correlations described in outcome 14 differ in Liraglutide 3.0 vs. Placebo Group
Hunger/satiety will be measured via ghrelin
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in energy intake
Energy intake will be assessed via ad libitum feeding
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Prediction of weight loss after 16 weeks intervention by assessing early changes in hunger/satiety
Hunger/satiety will be measured via ghrelin
Time frame: Baseline, Week 4, and Week 16