CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Saline +4 moredrug
Likely dose
Saline 0.83 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01520454
NCT01520454N/ACompleted

Differential Effects of Oral and Intravenous Lipid Administration on Leptin Signaling

Beth Israel Deaconess Medical Center·interventional·Posted Jan 30, 2012·Updated May 11, 2018

In Brief

A clinical study evaluating Saline, Intralipid, and 3 other interventions for Obesity and Leptin Resistance. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Obese people have elevated levels of the hormone leptin. Despite this, they seem to be resistant to the effects of this hormone, which usually regulates appetite and energy expenditure. This is similar to what happens with insulin levels in the obese. Furthermore, the way lipid ingestion versus lipid infusion may impact novel molecules secreted by tissues commonly affected in insulin resistant states such as liver and muscle have not yet been studied. The aim of the present study is to investigate the effect of oral vs. different doses of IV lipid administration on molecular parameters related to glucose and energy homeostasis using a randomized, placebo-controlled design. Additionally, we will examine how increased free fatty acids (FFAs) my impact intracellular leptin signaling such as the STAT3 pathway.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2012
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.4 years ago

Interventions

Salinedrug

IV saline at 0.83 mL/kg/hr for six hours

Intralipiddrug

Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours

Waterdietary

Water by mouth

oral fatdietary

Soybean oil by mouth at 1.25 g/kg x 2 doses

Heparindrug

Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours