A Study to Evaluate the Effect of Lipid Infusion on TLR4 Signaling
This trial is active, not recruiting.
|Treatments||intralipid 20%, saline|
|Sponsor||The University of Texas Health Science Center at San Antonio|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||January 2008|
|End date||December 2013|
|Trial size||12 participants|
|Trial identifier||NCT01740817, 5R01DK080157, HSC20080015H|
The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like receptor 4 (TLR4) signaling in human subjects
|Intervention model||crossover assignment|
|Primary purpose||basic science|
Muscle insulin sensitivity
time frame: 48 hr after lipid/saline infusion
time frame: 48 hr following lipid/saline infusion
Male or female participants from 18 years up to 60 years old.
- Subjects must have the following laboratory values: Hematocrit ≥ 35%, serum creatinine ≤ 1.5 mg/dl, aspartate aminotransferase (AST) < 2 X upper limit of normal, Alanine aminotransferase (ALT) < 2 X upper limit of normal, alkaline phosphatase < 2 X upper limit of normal, normal urinalysis [no glucose, trace protein, trace ketones, lipase < 50 IU/L, no bacteria, up to 1-3 white blood cells (WBC) and red blood cells (RBC) per hpf], and normal platelets, prothrombin time (PT) and partial thromboplastin time (PTT).
- Female subjects must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months.
- Subjects whose body weight has been stable (within 2%) for at least three months.
- Subjects with impaired glucose tolerance based on American Diabetes Association criteria.
- Subjects taking drugs known to affect glucose and lipid homeostasis will be excluded. Statins will be permitted if the subject has been on a stable dose for at least three months. Subjects who have taken for more than a week non-steroidal anti inflammatory drugs (NSAIDS) within two months or systemic steroids, anabolic steroids, growth hormone or immunosuppressants within 12 months will be excluded. Subjects taking low-dose (81 mg/day or less) aspirin will be allowed.
- Patients with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
- Recent systemic or pulmonary embolus, impaired renal function, poorly controlled blood pressure (systolic BP>170, diastolic BP>95), resting heart rate >100, electrolyte abnormalities, neuromuscular or musculoskeletal disease.
- Subjects who smoke.
- Subjects who engage in a regular exercise program (zero or one exercise sessions per week are allowed).
- Any subject who has donated blood in the previous two months.
- Any subject with a hematocrit of less than 35.
- Subjects who are claustrophobic.
- Women taking oral contraceptives.
- alcohol consumption greater than 30 grams daily.
- baseline plasma triglyceride levels over 200 mg/dl
|Official title||A Randomized, Crossover Study to Evaluate the Effect of Lipid Infusion on TLR4 Signaling and Insulin Resistance in Human Muscle|
|Principal investigator||Nicolas Musi, MD|
|Description||The investigators plan to examine the effect of a lipid infusion on TLR4 expression and insulin sensitivity. A group of 30 subjects aged 18-60 years old, lean (BMI < 26 kg/m2) normal glucose tolerant subjects without a family history of type 2 diabetes will receive a lipid or saline infusion. The subjects will be randomly assigned to first receive either a 48 hour long lipid or saline infusion. Approximately 4-6 weeks later subjects will return to undergo another study (if, in the first study they received lipid, on the second study they will receive saline, and vice versa). A near-equal number of women and men will be included in each group.|
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