Effect of Increased Free Fatty Acids on Leptin Function

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Leptin Resistance

In brief

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.

Key facts

Study ID

NCT01520454

Run by

Beth Israel Deaconess Medical Center

People needed

26

Starts

2011-11-01

Expected to finish

2016-12-01

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-65

You may not qualify if…

• Subjects with a history of any illness, other than obesity, that may affect insulin sensitivity (anemia, infectious diseases, renal or hepatic failure, uncontrolled hypertension, cancer, lymphoma, chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis, states of cortisol or growth hormone excess, alcoholism or drug abuse, and eating disorders).
• History of diabetes mellitus.
• Subjects taking any medications that are known to influence glucose metabolism such as glucocorticoids will also be excluded. We will screen for these conditions by means of a detailed history and review of systems and physical examination (see below).
• Subjects taking any medications known to affect lipids such as statins will also be excluded. We will screen for these similar to above.
• Cholesterol greater or equal to 250 mg/dL and/or triglyceride levels greater than 500 mg/dL at the time of screening, as determined by laboratory testing.
• Subjects who have a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Marcaine will be excluded from the study.
• Hypersensitivity to fat emulsion or any component of the formulation; severe egg or legume (soybean) allergies; pathologic hyperlipidemia, lipoid nephrosis, acute pancreatitis associated with hyperlipemia.
• Hypersensitivity to heparin or any component of the formulation
• Severe thrombocytopenia, uncontrolled active bleeding, disseminated intravascular coagulation (DIC); suspected intracranial hemorrhage.
• Subjects with a history of bleeding dyscrasia, poor wound healing or any medical condition precluding supine position will be excluded from the study.
• Unable to follow study protocol or any condition that in the opinion of the investigator makes the subject unsuitable for the study.
• Pregnancy
• Prior history of gastrectomy, gastric bypass surgery, or other weight loss surgery.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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