HealthyNCT00001722
Fat Tissue Microperfusion to Measure Leptin Secretion and Its Relations With Fat Breakdown in Humans
An observational study of Healthy and Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Jul 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects ages 18 to 50 years.
- Healthy volunteers studied as outpatients.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: Adipose Tissue Microperfusion to Assess Leptin Secretion and Its Relations With Lipolysis in Humans
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.
Read the 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.
- Keywords
- Obesity, Sympathetic Nervous System, Fat Tissue, Metabolism, Adipose Tissue, Microdialysis, Leptin, Lipolysis, Normal Volunteer
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startApr 1998
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001722
- Sponsor's protocol ID
- 980103
- Other IDs
- 98-CH-0103
- Status last verified
- Jul 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 7984236Campfield 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.
PubMed 9013731Caro 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.
PubMed 8866547
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Microperfusion to Assess Leptin Secretion and Its Relations With Lipolysis in Humans
- ClinicalTrials.gov ID
- NCT00001722
- Acronym / sponsor ID
- 980103
- Keywords
- Obesity, Sympathetic Nervous System, Fat Tissue, Metabolism, Adipose Tissue, Microdialysis, Leptin, Lipolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Apr 1998
- Study completion
- Jul 2003
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects ages 18 to 50 years.
- Healthy volunteers studied as outpatients.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7984236Zhang 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.
- Background: PubMed 9013731Campfield 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.
- Background: PubMed 8866547Caro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.