Phase
Condition
Hormone Deficiencies
Diabetes (Pediatric)
Diabetes Prevention
Treatment
Intralipid, 20% Intravenous Emulsion
Clinical Study ID
Ages 18-44 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects who are able to provide written informed consent and to comply with theprocedures of the study protocol
Exclusion
Exclusion Criteria:
History of diabetes
History of diabetes in more than one first-degree relative
Body mass index (BMI) <19 or >27 kg/m2
HbA1c >5.7%
Blood Pressure: systolic >160 mmHg or diastolic > 100 mmHg
Baseline hemoglobin concentration < 11 g/dl in women and < 12 g/dl in men
Estimated glomerular filtration rate < 55 ml/min/1.73 m2 (calculated using thesubject's measured serum creatinine and the Modification of Diet in Renal Disease [MDRD] study estimation formula).
Presence of soy or egg allergies (due to possible reactions with fat infusate)
For female participants: Positive pregnancy test, presently breast-feeding, orunwillingness to use effective contraceptive measures for the duration of the study.Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicideare acceptable contraceptive methods; condoms used alone are not acceptable.
Known active alcohol or substance abuse
Use of tobacco within the previous year
Severe co-existing cardiac disease, characterized by any one of these conditions:
history of myocardial infarction within past 6 months;
history of ischemia on functional cardiac exam within the last year;
history of left ventricular ejection fraction < 30%.
Persistent elevation of liver function tests > 1.5 times normal upper limits
Hyperlipidemia (fasting LDL cholesterol > 130 mg/dl, treated or untreated; and/orfasting triglycerides > 200 mg/dl)
Receiving treatment for a medical condition requiring chronic use of systemicsteroids, except for the use of ≤ 5 mg prednisone daily, or an equivalentphysiological dose of hydrocortisone
Presence of a seizure disorder
Use of any investigational agents within 4 weeks of enrollment
Any medical condition, which in the opinion of the investigator, will interfere withthe safe completion of the study
History of pancreatitis
Presence of a metal allergy (aluminum)
Study Design
Study Description
Connect with a study center
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available

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