NCT00001722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

ObesitySympathetic Nervous SystemFat TissueMetabolismAdipose TissueMicrodialysisLeptinLipolysisNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects ages 18 to 50 years.
  • Healthy volunteers studied as outpatients.

You may not qualify if:

  • Minors (less than 18 years of age)
  • Subjects taking any medication on a regular basis.
  • Individuals with hepatic, renal, HPA axis or thyroid dysfunction.
  • Very lean individuals (defined as a body mass index less than 19).
  • Smokers.
  • Pregnant or lactating woman.
  • Individuals with allergies to teflon, polyethylene or skin tape.
  • Individuals with known allergy to isoproterenol.
  • Individuals unable to abstain from alcohol, tobacco, tea, and coffee for 18 hours prior and during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Zhang Y, Proenca R, Maffei M, Barone M, Leopold L, Friedman JM. Positional cloning of the mouse obese gene and its human homologue. Nature. 1994 Dec 1;372(6505):425-32. doi: 10.1038/372425a0.

    PMID: 7984236BACKGROUND
  • Campfield LA, Smith FJ, Burn P. The OB protein (leptin) pathway--a link between adipose tissue mass and central neural networks. Horm Metab Res. 1996 Dec;28(12):619-32. doi: 10.1055/s-2007-979867.

    PMID: 9013731BACKGROUND
  • Caro JF, Sinha MK, Kolaczynski JW, Zhang PL, Considine RV. Leptin: the tale of an obesity gene. Diabetes. 1996 Nov;45(11):1455-62. doi: 10.2337/diab.45.11.1455. No abstract available.

    PMID: 8866547BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 1, 1998

Study Completion

July 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-07

Locations