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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT01562678
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes
  • Effects of Liraglutide Administration on Brain Activity
  • Hunger
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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: 1. The impact of Liraglutide on brain responses to food 2. It's effect on physiological and mental performance 3. If its effect on the brain differs among obese and lean diabetic subjects.

Key Dates

Start date
Mar 31, 2012
Status verified
Apr 2017
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

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Beth Israel Deaconess Medical Center· Boston, MA

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