Viewing Study NCT00001722



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001722
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Fat Tissue Microperfusion to Measure Leptin Secretion and Its Relations With Fat Breakdown in Humans
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Adipose Tissue Microperfusion to Assess Leptin Secretion and Its Relations With Lipolysis in Humans
Status: COMPLETED
Status Verified Date: 2003-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Leptin is a hormone that acts in the body as a chemical messenger It is produced in fat cells and is believed to regulate body weight in humans Leptin decreases appetite and influences the energy balance of the body

This study will attempt to measure levels of leptin production in the fat pad of the body by using a process called microperfusion Microperfusion works by inserting 2 to 3 probes thin tubes into the fat pad around the belly button These probes can measure chemicals in an area known as the extracellular space This is the small space between cells and blood vessels that hormones medicines nutrients and salts travel through

The study will investigate the effects of a meal insulin glucose sugar and the medication isoproterenol on leptin levels Researchers believe that leptin levels are regulated along with the enzyme hormone sensitive lipase HSL When hormone sensitive lipase is activated fat is broken down in a process called lipolysis In addition increased levels of HSL result in decreased levels of leptin which in turn increases appetite and food intake
Detailed Description: The adipocyte hormone leptin serves as a humoral signal of energy stores acting on central neuronal networks that regulate ingestive behavior and energy balance The basis for the circadian rhythm and pulsatility of circulating leptin levels in the face of a relatively stable adipose mass is not known We have already established the feasibility and validity of adipose tissue microperfusion in humans for measurements of leptin in adipose tissue interstitial fluid The aim of this study now is to assess the specific aspects of the regulation of adipose tissue metabolism in situ

The hormone sensitive lipase HSL catalyzes the final rate limiting step of energy mobilization from adipose tissue Its activation results in hydrolysis of triglycerides a process referred to as lipolysis Increased HSL activity during fasting and stress is physiologically coupled with significant reductions in circulating leptin levels which in turn results in increased food intake and thus restoration of energy balance We hypothesize that local neural signals from the sympathetic nervous system to adipocytes through beta-adrenergic receptors simultaneously regulate leptin secretion and lipolysis the latter via the modulation of HSL activity This hypothesis will be tested by measurements of interstitial levels of leptin and glycerol in adipose tissue in situ before and after local administration of a beta-adrenergic agonist Food intake and beta-adrenergic stimulation are excellent potential stimuli in the study of the novel fat-derived hormones resistin and adiponectin

We hypothesize that insulin has regulatory effects on leptin secretion and lipolysis This hypothesis will be tested by measurement of interstitial levels of leptin TNF-alpha and interleukin-6 in adipose tissue in situ and after local administration of insulin

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
98-CH-0103 None None None