- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01738802
The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes (PMC)
27. april 2016 opdateret af: Alicia L. Warnock, Walter Reed National Military Medical Center
This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes.
The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months.
The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
111
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 20889
- Walter Reed National Military Medical Center
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Bethesda, Maryland, Forenede Stater, 20889-5600
- Walter Reed National Military Medical Center
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-
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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of Type 2 diabetes of at least three months duration
- 50 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
- Not taking or not expected to be taking any oral glucocorticoids (except for replacement therapy for those with adrenal insufficiency), amphetamines, anabolic, or weight-reducing agents during the course of the study
- Not receiving chemotherapy or immunosuppressive therapy
- Military healthcare beneficiary
Exclusion Criteria:
- Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
- Inability to communicate in written and spoken English
- Organ (kidney, pancreas, liver) transplant recipients
- Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
- Pregnancy (Women who are pre-menopausal will be informed that pregnancy must be ruled out by a serum HCG test if they would like to be considered for participation in the study. Women who have had a hysterectomy or have not had a menstrual period for at least one year prior to consent will be considered post-menopausal and will not require a serum pregnancy test).
- Patients who are routinely taking more than 81 mg aspirin (ASA)/day or who are using ASA or ASA-containing products to manage a chronic condition.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Anti-oxidant and micronutrient
This group will take the anti-oxidant and micronutrient supplement.
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This group will be randomized to take the anti-oxidant and micronutrient supplement.
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Placebo komparator: Placebo
This group will take the placebo.
|
This group will take a placebo.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in the markers of oxidative stress and inflammation
Tidsramme: baseline, 6, and 12 months
|
Determining a difference between the control and experimental groups in the following markers of 1) oxidative stress: 9-Malondialdehyde (MDA) in plasma, 3-Nitrotyrosine in plasma, and Urinary levels of F2-isoprostane and 8 hydroxy,deoxyguanosine; and 2) inflammation: GM-CSF, IFN-γ, IL-1β, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-α.
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baseline, 6, and 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in CIMT
Tidsramme: Baseline, 6 and 12 months
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Determine if a difference exists in CIMT measurements between the control and experimental groups.
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Baseline, 6 and 12 months
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Change in medications
Tidsramme: Baseline, 3, 6, 9, and 12 months
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Compare the experimental and control groups to determine if medication use has changed over the course of the study.
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Baseline, 3, 6, 9, and 12 months
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Change in lipid profile
Tidsramme: baseline, 3, 6, 9, and 12 months
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Compare the control and experimental groups to determine differences in lipid profile over time.
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baseline, 3, 6, 9, and 12 months
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Hemoglobin A1c
Tidsramme: baseline, 3, 6, 9, and 12 months
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Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.
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baseline, 3, 6, 9, and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Robert Vigersky, MD, WRNMMC
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. januar 2012
Primær færdiggørelse (Faktiske)
1. april 2016
Studieafslutning (Faktiske)
1. april 2016
Datoer for studieregistrering
Først indsendt
19. juli 2012
Først indsendt, der opfyldte QC-kriterier
27. november 2012
Først opslået (Skøn)
30. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 361813
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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