NCT01562678

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. Vital signs (blood pressure, temperature, heart rate, breathing rate) 2. Height, weight and other body measurements like waist 3. Blood tests 4. Urine pregnancy test (women only) 5. Electrocardiogram (EKG) 6. Medical history 7. Physical exam 8. Body Composition tests 9. Study logs to record food intake and blood sugar 10. 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Liraglutide	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.
DRUG	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-03-26
• Last updated: 2017-05-31
• Results posted: 2017-05-31

Locations

1 site across 1 country: United States