Status:
COMPLETED
Effect of Increased Free Fatty Acids on Leptin Function
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Obesity
Leptin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 simila...
Detailed Description
We propose to test our hypotheses by conducting a non-blinded, interventional study evaluating the effects of acute leptin administration on intracellular leptin signaling pathways after a 6 hour infu...
Eligibility Criteria
Inclusion
- Age 18-65
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01520454
Start Date
November 1 2011
End Date
December 1 2016
Last Update
May 11 2018
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215