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ACTIVE NOT RECRUITING
NCT01239550
NA

Insulin Detemir in Obesity Management

Sponsor: Vanderbilt University

View on ClinicalTrials.gov

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

Conditions

Interventions

DRUG

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