- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00330967
Mechanisms of Insulin Resistance in Humans
17 mars 2015 uppdaterad av: US Department of Veterans Affairs
The Objectives of the study are to: (1)compare the inflammatory response and insulin resistance in skeletal muscles during a systemic infusion of lipid with that during a local infusion of lipid into the femoral artery.
which would cause minimal or no systemic hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during the systemic lipid infusion, and (2) determine the inflammatory response and insulin resistance in skeletal muscle during an infusion of lipid into the femoral artery as described above after NF-KB inhibition by high dose salicylate treatment in humans.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Insulin resistance in skeletal muscle is a characteristic abnormality in obesity and the metabolic syndrome and a major factor responsible for the development of type 2 diabetes.
Although the mechanisms responsible for muscle insulin resistance are largely unclear, lipid oversupply is an important factor.
Among numerous potential mechanisms whereby lipid oversupply may cause muscle insulin resistance, current evidence points towards inflammation as being critical.
Recent studies in animals, however, indicate that the inflammatory response in skeletal muscles may require the presence of circulating pro-inflammatory factors suggesting that the inflammation induced insulin resistance in skeletal muscles may be a secondary event.
More specifically, activation of Nuclear Factor-Kappa B(NF-kB), and inflammatory master switch that drives the production of numerous pro-inflammatory cytokines in fat and liver, has been implicated in causing insulin resistance in skeletal muscles by increasing circulating pro-inflammatory cytokines.
In contrast, animal studies have found that activation of NF-KB directly in skeletal muscles has no or little effect on its insulin sensitivity but does produce other abnormalities such as increased proteasome activity.
The study shall therefore be undertaken to determine to what extent lipid-induced inflammation and insulin resistance in skeletal muscles requires the presence of circulating proinflammatory factors in humans.
Studietyp
Observationell
Inskrivning (Faktisk)
25
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85012
- Phoenix VA Health Care System Carl T. Hayden VA Medical Center, Phoenix, AZ
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
healthy subjects
Beskrivning
Inclusion Criteria:
- two groups of 16 healthy subjects
Exclusion Criteria:
- diabetes or impaired glucose tolerance
- peripheral vascular disease
- pulmonary disease
- clinically significant hepatic or renal disease
- triglycerides >200mg/dl
- anemia
- abnormal PT, PTT or INR
- pregnancy or lactation
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Group 1
healthy subjects
|
lipid infusion
|
Group 2
healthy subjects different from group 1
|
lipid infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Insulin Signaling With Lipid Infusion
Tidsram: 4 h
|
IRS-1 expression in response to femoral lipid infusion in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.
|
4 h
|
Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions.
phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
p38 MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
ERK MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
JNK MAPK Expression With Femoral Lipid and Insulin Infusions
Tidsram: 4 h
|
JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle.
Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.
|
4 h
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Charles C Oh, MD, Phoenix VA Health Care System Carl T. Hayden VA Medical Center, Phoenix, AZ
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2006
Primärt slutförande (Faktisk)
1 januari 2012
Avslutad studie (Faktisk)
1 augusti 2014
Studieregistreringsdatum
Först inskickad
26 maj 2006
Först inskickad som uppfyllde QC-kriterierna
26 maj 2006
Första postat (Uppskatta)
29 maj 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 mars 2015
Senast verifierad
1 mars 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ENDA-029-05F
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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