- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01173705
Factors Involved in Obesity-related Inflammation and Insulin Resistance
Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance
In this project, we propose to recruit lean and obese subjects with different ethnic background (African Americans and Caucasians) to study the alterations of lipid and carbohydrate metabolism and determine whether these disturbances are linked to genetic, inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and insulin resistance are frequent features of obesity, we postulate that an unbalanced diet with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation and insulin resistance. We propose to investigate fatty acid metabolism and determine the links between fatty acid composition and oxidative stress in tissues of lean and obese subjects. We propose the following aims:
Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES Food Questionnaire.
Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3 content and inflammatory and oxidative stress markers.
Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 18-65 years of age
- Undergoing elective abdominal or bariatric surgery
Exclusion Criteria:
- Intercurrent infections
- Active cancer diagnosis within 5 years
- Use of medications for diabetes or hyperlipidemia
- Use of glucocorticoids or anti-inflammatory drugs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Normal weight: abdominal surgery
Lean individuals undergoing elective abdominal surgery
|
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Obese: abdominal or bariatic surgery
Obese subjects undergoing elective abdominal or bariatric surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Examine the relationship between omega-3 content and inflammatory and oxidative stress markers
Tidsramme: 5 years
|
We will evaluate fatty acid composition in adipose tissues depots, blood monocytes, and skeletal muscle to examine the relationship between omega-e content and inflammatory and oxidative stress markers.
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate nutrient intake
Tidsramme: 5 years
|
Using the NHANES Food Questionnaire, we will evaluate nutrient intakes of lean and obese individuals
|
5 years
|
|
Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)
Tidsramme: 5 years
|
Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Robyn Tamboli, PhD, Vanderbilt University Medical Center
- Studiestol: Naji N Abumrad, MD, Vanderbilt University Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB #100919
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