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Iron Depletion Therapy for Type 2 DM and NAFLD

19. juli 2026 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Iron Depletion Therapy for Patients With Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Nonalcoholic fatty liver disease (NAFLD) is a common liver disease in the United States. NAFLD can lead to severe liver disease in some patients. Patients with NAFLD develop resistance to the normal action of insulin. Insulin is important for processing sugar and fat and increased resistance to insulin leads to fat in the liver. There is a correlation between the amount of iron in a person's body and the ability of insulin to work properly. Several small studies suggest that removal of iron may improve both diabetes and NAFLD by lowering insulin resistance.

The goal of this pilot study is to determine the effect of iron depletion on insulin sensitivity in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease. This study will be performed as an ancillary P&F study to the NASH CRN; all participants will be recruited from the NASH CRN Database Study. Secondary outcome measures will include the effect of iron depletion on hepatic necroinflammation, markers of oxidative stress and intrahepatic fat content. Insulin resistance will be directly measured using a two-step hyperinsulinemic euglycemic clamp procedure, before and after iron depletion by phlebotomy. Oral glucose tolerance tests will also be performed in order to evaluate the efficacy of using the indirect, but less cumbersome, HOMA model to derive values of insulin resistance in this patient cohort. This study will advance our understanding of the role of body iron stores in the pathophysiology of type 2 diabetes mellitus and non-alcoholic fatty liver disease. If iron depletion results in improved insulin sensitivity, reduced hepatic necroinflammation and/or intrahepatic fat content, a large scale, randomized, controlled trial of iron depletion in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease will be planned.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  • Histological evidence of NAFLD and enrollment in NASH CRN Database Study
  • Type 2 DM treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for > 3 mo.
  • Hemoglobin HbA1c level ≤ 8 %
  • Serum ALT levels ≥1.3 x ULN
  • Between 18-65 years of age

Exclusion Criteria

  • Hereditary hemochromatosis or hepatic iron overload defined as any of the following:

    • 2+ iron on hepatic iron staining
    • Hepatic Iron Index ≥ 1.9
    • C282Y homozygous or C282Y/H63D compound heterozygous HFE genotype
  • Use of insulin or thiazolidinediones for the treatment of diabetes
  • Use of anti-NASH drugs (thiazolidinediones, vitamin E, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics)
  • Serum ferritin <50μg/L
  • Serum transferrin-iron saturation <10 %
  • Hemoglobin <10 mg/L
  • Hematocrit <38 %
  • Voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
  • Pregnant or lactating women
  • Prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
  • Evidence of myocardial infarction as determined by an ECG

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phlebotomy
Blood donation
Procedure: blood donation
phlebotomy until iron depleted

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Improved insulin sensitivity as determined by:(1) hyperinsulinemic euglycemic clamp method
Tidsramme: one year
one year
(2) HOMA model- determined by the OGTT method
Tidsramme: one year
one year

Sekundære resultatmål

Resultatmål
Tidsramme
Change in serum aminotransferase levels Change in levels of serum, plasma and urinary markers of oxidative stress
Tidsramme: one year
one year
Changes in intrahepatic and intraabdominal fat content as determined by CT scan
Tidsramme: one year
one year
Change in serum levels of proinflammatory cytokines (ie IL-6, TnF-αR2)
Tidsramme: one year
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Kris V Kowdley, MD, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

29. september 2005

Først indsendt, der opfyldte QC-kriterier

29. september 2005

Først opslået (Anslået)

30. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DK 61728-S1 (completed)
  • U01DK061728 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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