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Insulin Detemir in Obesity Management
Sponsor: Vanderbilt University
Summary
The purpose of this study is to evaluate the effects of the medication insulin detemir on weight, brain function and mood, and on blood vessel and other risk factors for heart disease. The study will compare how diet and insulin detemir affect areas of the brain that are involved in food intake and the sense of pleasure people get from eating. Participants will be randomized into one of 2 groups. Group 1 will follow a low calorie diet only. Group 2 will follow a low calorie diet and take insulin detemir. The study is 26 weeks in length and include outpatient visits, inpatient visits, phone and email contact, questionnaires, diary collection, blood draw and procedures involving MRI and PET scans. There are 4 inpatient visits at the Vanderbilt Clinical Research Center (CRC). The inpatient visits require a one night 2 day stay on the CRC at Weeks 2, 6, 16, 26. During the weekly and bi-weekly outpatient visits participants will meet with the study nurse and dietitian.
Official title: Making an "Obese"Brain(and Body)Lean: Insulin Detemir,Monoamines,and Reward
Key Details
Gender
All
Age Range
31 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2011-04
Completion Date
2028-12
Last Updated
2026-01-23
Healthy Volunteers
No
Interventions
Detemir
Subjects randomized to insulin detemir treatment group will receive the basal insulin in a 3 mL. Flex Pen® containing 300 units of insulin. insulin detemir once daily administered with the evening meal (dinner) or at bedtime as add-on to their oral antihyperglycemia (see inclusion/exclusion criteria) meds throughout the 24 week treatment period. The goal of insulin therapy is to achieve near normoglycemia with a low rate of hypoglycaemic episodes. Insulin injections will be given subcutaneously preferably in the thigh or abdomen.
Locations (1)
Vanderbilt University
Nashville, Tennessee, United States