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Insulin Detemir in Obesity Management

NCT01239550 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-23

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Kevin D Niswender, MD/PhD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
31 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239550 on ClinicalTrials.gov