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Insulin Detemir in Obesity Management

Study acronym: IDIOM
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 2028v13
  2. Re-verified, no change to tracked fieldsv12
  3. Primary and study completion dates: Dec 2023 to Dec 2025v11
  4. Primary and study completion dates: Dec 2022 to Dec 2023v10
  5. Primary and study completion dates: Dec 2020 to Dec 2022v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Dec 2019 to Dec 2020v8
  2. Re-verified, no change to tracked fieldsv7
  3. Primary and study completion dates: Dec 2017 to Dec 2019v6
  4. Primary completion date: Dec 2015 to Dec 2017
    • Study completion date: Dec 2016 to Dec 2017
    v5
  5. Primary completion date: Oct 2013 to Dec 2015
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 2014 to Dec 2016
    • Site details revised
    v4
  6. Re-verified, no change to tracked fieldsv3
  7. Phase: Phase 3 to Not applicablev2 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2012 to Oct 2013
    • Start date: Jan 2011 to Apr 2011
    • Study completion date: Jan 2013 to Jan 2014
    • Eligibility criteria shortened, about 29 words
    • Study description expanded, about 1,183 words
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Vanderbilt University
47 trials monitored
See 4 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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.
Trial Details
NCT Number NCT01239550
Lead Sponsor Vanderbilt University
Collaborators: Novo Nordisk A/S
Conditions
(from sponsor)		 Diabetes, Obesity
Related terms Diabetes Mellitus, Insulin Resistance, Obesity
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov