The Impact of Omega-3 Supplementation on Gene Expression in Type 2 Diabetics
30. november 2012 opdateret af: Tehran University of Medical Sciences
The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2
The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Adipose tissue is recognized as an important endocrine organ in human.
Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years.
Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes.
C5L2 is a G-protein-coupled receptor.
activation of C5L2 by ASP, has been shown.
Fatty acids may influence the expression of adipokines.
Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes.
Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Tehran, Iran, Islamisk Republik
- Tehran University of Medical Sciences
-
-
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
30 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- literate
- Willingness to participation
- Diabetic patients 30-65 years old
- Body mass index in the range 18.5-40
- Avoidance of dietary supplements
- vitamins and herbal products at least 2 weeks before and throughout the intervention
Exclusion Criteria:
- people who have used omega-3 supplements in last 3 months
- Having chronic renal disease
- hepatic disease
- gastrointestinal disease
- hematological disorders
- hypothyroidism or hyperthyroidism
- Treatment with Orlistat or sibutramine for weight loss
- Pregnancy and lactation
- Treatment with insulin or Thiazolidinediones
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: diabetes, omega-3
patient with type 2 diabetes who receive 4gr/day omega-3
|
4 cap 1 gr omega-3 per day for 10 weeks
Andre navne:
|
|
Placebo komparator: placebo, diabetes
patient with type 2 diabetes who receive 4 cap of placebo/day
|
patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serum total cholesterol
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
serum High-density lipoprotein (HDL) cholesterol
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
serum Low-density lipoprotein (LDL) cholesterol
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
serum triglycerides (TG) level
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
postprandial triglycerides
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
complete blood count(CBC)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
fasting plasma glucose(FPG)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
Glycated hemoglobin (Hb A1c)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
acylation stimulating protein (ASP)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
lipocalin-2 (LCN2)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
Retinol-binding protein 4 (RBP4)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
non-esterified fatty acids (NEFA)
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
insulin
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
|
postprandial ASP
Tidsramme: chage from baseline at 10 weeks
|
chage from baseline at 10 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
gene expression of C5L2
Tidsramme: change from baseline at 10 weeks
|
change from baseline at 10 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. december 2011
Primær færdiggørelse (Forventet)
1. marts 2013
Studieafslutning (Forventet)
1. september 2013
Datoer for studieregistrering
Først indsendt
21. november 2011
Først indsendt, der opfyldte QC-kriterier
22. november 2011
Først opslået (Skøn)
23. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2012
Sidst verificeret
1. november 2012
Mere information
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 .