NCT01520454|CompletedResults
Effect of Increased Free Fatty Acids on Leptin Function
Differential Effects of Oral and Intravenous Lipid Administration on Leptin Signaling
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Sponsor study identifier
interventional
26
1 country
1
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 4, 2012
Actual (reported)January 30, 2012
Actual (reported)December 2013
Actual (reported)December 2016
Actual (reported)April 26, 2017
Actual (reported)Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels
The GLP-1 area under the curve (AUC) was calculated from baseline to six hours
Baseline to 6 hours
Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels
The GIP AUC fwas calculated from baseline to six hours
Baseline to 6 hours
Change in Circulating Ghrelin Levels
The Ghrelin AUC was calculated from baseline to six hours
Baseline to 6 hours
Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels
The PYY AUC was calculated from baseline to six hours
Baseline to 6 hours
Change in Circulating Glucose Levels
Baseline to 6 hours
Change in Circulating Insulin Levels
Baseline to 6 hours
Change in Circulating Leptin Levels
Baseline to 6 hours
Change in Circulating Adiponectin Levels
Baseline to 6 hours
Phosphorylation of STAT3 Pathways Downstream of Leptin After Lipid Administration
Baseline to 6 hours
IV saline with heparin, oral water
Intralipid at high dose, with heparin and PO water
Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.
Christos S Mantzoros, MD, DSc
Beth Israel Deaconess Medical Center
26 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2012
First Posted
January 30, 2012
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Activation of Brain Centers by Short-term Walnut Consumption in Obesity
Progressive Resistance Training in Patients With Class III Obesity
Low dose IV Intralipid with heparin and PO water
Oral fat load with IV saline
Soybean oil by mouth at 1.25 g/kg x 2 doses
Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
May 11, 2018
Results First Posted
April 26, 2017
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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