N/A
N=25
Mechanisms of Insulin Resistance in Humans
Inflammation · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT00330967 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Mar 2015
Primary outcome: Primary: Insulin Signaling With Lipid Infusion — 0.4334; 0.7276; 0.5264; 0.3534 ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 20% Intralipid (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Signaling With Lipid Infusion |
0.4334; 0.7276; 0.5264; 0.3534 | — |
| PRIMARY Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions |
0.000394; 0.001271; 0.000337; 0.000270 | — |
| PRIMARY p38 MAPK Expression With Femoral Lipid and Insulin Infusions |
0.000455; 0.001291; 0.000502; 0.000377 | — |
| PRIMARY Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions |
0.000091; 0.000108; 0.000096; 0.000092 | — |
| PRIMARY ERK MAPK Expression With Femoral Lipid and Insulin Infusions |
0.000103; 0.000158; 0.000124; 0.000114 | — |
| PRIMARY Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions |
0.00401; 0.005888; 0.003756; 0.00224 | — |
| PRIMARY JNK MAPK Expression With Femoral Lipid and Insulin Infusions |
0.001364; 0.002996; 0.002151; 0.001783 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00330967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.