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Effect of Increased Free Fatty Acids on Leptin Function

NCT01520454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-05-11

Study results available
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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.

Conditions

Interventions

DRUG

Saline

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

DRUG

Intralipid

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

DIETARY_SUPPLEMENT

Water

Water by mouth

DIETARY_SUPPLEMENT

oral fat

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

DRUG

Heparin

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

Sponsors & Collaborators

Principal Investigators

  • Christos S Mantzoros, MD, DSc · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520454 on ClinicalTrials.gov