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Iron Depletion Therapy for Type 2 DM and NAFLD

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Phase: Phase 2 to Not applicable

    Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventionsv13

  2. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v12

  3. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv11

  4. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv10

  5. Notable

    Primary and study completion dates: Feb 2009 to Jun 2010

    Study Statusv9

Show 7 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  2. Minor

    Completion date: Oct 2008 to Feb 2009

    Study Statusv7

  3. Minor

    Primary completion date: Feb 2009

    Completion date: Oct 2007 to Oct 2008; Interventions: iron depletion by phlebotomy (Procedure) to blood donation (Procedure); Secondary endpoints: details revised at 3 of 3 entries

    Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Outcome Measures, Contacts/Locationsv6

  4. Minor

    2 amendments

    2 re-verifications since 2007-03-01, no change to tracked fields

    v4-v5

  5. Notable

    Primary endpoints: 3 to 2

    Secondary endpoints: 4 to 3

    Show what changed: Primary endpoints
    • Improved insulin sensitivity as determined by:⇅ moved (1) hyperinsulinemic euglycemic clamp method
    Show what changed: Secondary endpoints
    • Change in serum aminotransferase levels • Change in levels of serum, plasma and urinary markers of oxidative stress • Changes in intrahepatic and intraabdominal fat content as determined by CT scan • Change in serum levels of proinflammatory cytokines (ie IL-6, TnF-αR2)

    Study Status, Outcome Measuresv3

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to find out whether lowering the amount of iron in the body will result in less resistance to insulin and improved liver function in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes control and/or a decrease in the amount of liver fat.
Trial Details
NCT Number NCT00230087
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Non-Alcoholic Fatty Liver Disease, Diabetes Mellitus
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov