- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02261545
The Effect of n-3 Fatty Acid Supplementation on Serum Levels, and Gene Expression of type2 Diabetes Patient
17. november 2015 opdateret af: Tehran University of Medical Sciences
The Effect of n-3 Fatty Acid Supplementation on the Expression of Sirt-1, Adiponectin Receptor 1 (AdipoR1) & Adiponectin Receptor 2 (AdipoR2) Genes of PBMC and Circulatory Levels of Resistin,Monocyte Chemotactic Protein (MCP-1) and Adiponectin of type2 Diabetes Patient
The aim of this study is to determine the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1 & AdipoR2 genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 and Adiponectin of type2 diabetes patient
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The aim of this study is to determine of the effects of supplementation with n-3 fatty acid or placebo for 10 weeks on the expression of Sirt-1, AdipoR1(adiponectin receptor 1) & AdipoR2 (adiponectin receptor 2) genes in the peripheral blood mononuclear cell (PBMC) and circulatory levels of Resistin, MCP-1 (Monocyte Chemoattractant Protein-1) and Adiponectin of type2 diabetes patient.
In this randomized, double-blind clinical trial, placebo-controlled, 88 men and women with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association.
After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days and beck depression questionnaire will be taken from the participants at the beginning and the end of the study.
Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo.
The supplement group, will receive mg 1800mg EPA(Eicosapentaenoic acid ) & 900mg DHA( docosahexaenoic acid) (total=2700mg) for 10 weeks and the placebo group will also receive placebo (containing 2700 mg of edible paraffin) (similar in terms of color, shape and size).
Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity.
Blood samples will be collected after 12 hours fasting and anthropometric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
88
Fase
- Fase 4
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:
- willingness to participation,
- diabetic patients 30- 60 years old,
- body mass index in the range 25-40,
- avoidance of dietary supplements,
- vitamins and herbal products at least 3 months before and throughout the intervention
Exclusion Criteria:
- people who have used n-3 Fatty Acid Supplementation in last 3 months,
- having chronic renal disease ,
- GI disease,
- Hepatobiliary diseases,
- hematological disorders,
- hypo- or hyperthyroidism,
- type 1 diabetes,
- 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: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: n-3 Fatty Acid Supplemetation
patients with Type II Diabetes who receive 3 cap omega3, 3 times a day, for 10 weeks.
|
n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
Andre navne:
|
|
Placebo komparator: Placebo
patients with Type II Diabetes who receive 3 cap of placebo/ for 10 weeks.
|
3 cap 1 g Placebo(paraffin) per day for 10 weeks.
Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum Fasting Blood Sugar(FBS)
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum Insulin
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum HbA1C
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum Resistin
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum adiponectin
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum mcp-1
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Gene Expression of AdipoR1
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Gene Expression of AdipoR2
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Gene Expression of Sirt-1
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Beck depression score
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum cholesterol
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum LDL cholesterol
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
|
Serum TG
Tidsramme: Change from baseline at 10 weeks
|
Change from baseline at 10 weeks
|
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Serum HDL cholesterol
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.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 2014
Primær færdiggørelse (Forventet)
1. januar 2016
Studieafslutning (Forventet)
1. februar 2016
Datoer for studieregistrering
Først indsendt
7. oktober 2014
Først indsendt, der opfyldte QC-kriterier
9. oktober 2014
Først opslået (Skøn)
10. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25367
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 .