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

Diabetes Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

• NCT number: NCT01562678
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: March 2012
• Completion date: May 2014