- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00001543
Dynamics of Leptin and Endocrine Function
This is a study investigating the hormones and substances important to the stress response. The hormone that is most directly responsible for stress response is called corticotropin-releasing hormone (CRH). CRH is produced in the hypothalamus of the brain and causes the pituitary gland to produce another hormone called ACTH. The hormone ACTH then acts on the adrenal glands causing them to produce the hormone cortisol.
Unfortunately, CRH levels are unable to be measured in simple blood samples. However, substances like cortisol and leptin can provide information as to the activity of the hypothalamus.
The hormone leptin is associated with the regulation of body weight and the normal maintenance of bodily functions (homeostasis). It is found in fat cell (adipocyes) and communicates the nutritional status of the body to the brain (central nervous system). Research using animals has shown that defects in the communication between leptin and the brain causes obesity (the state of being overweight). It has also been noted that obese humans tend to have high levels of leptin.
By studying patients with abnormal genes responsible for leptin production, researchers have found that a least one leptin gene must be intact for the normal secretion of hormones to proceed. These results show that the hormone leptin is produced outside of the brain in fat cells and acts directly on the function of the hypothalamus within the brain. Researchers believe that leptin plays a key role in the normal release of hormones from the HPA axis.
Researchers intend on continuing to study the role of leptin in fat distribution, and the activity of the HPA axis in normal volunteers. In addition, this study will focus on the role of leptin in depression, because depression is characterized by changes in food intake, body weight, and neuroendocrine function. Data gathered from this study will provide a better understanding of the causes and medical consequences of major depression.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- National Institute of Mental Health (NIMH)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Depressed patients must have a history of past major depression of at least four months duration, or a history of two or more briefer episodes. Must be overweight.
Must not need a hospital admission as part of their treatment.
Overweight normal volunteers.
No subjects on chronic medication which cannot be washed out for one month.
No subjects with any serious medical illness.
No women who are pregnant, trying to become pregnant, or sexually active and not using effective contraception.
No patients with HIV infection.
No subjects who cannot discontinue use of alcohol/tobacco.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Behan DP, Linton EA, Lowry PJ. Isolation of the human plasma corticotrophin-releasing factor-binding protein. J Endocrinol. 1989 Jul;122(1):23-31. doi: 10.1677/joe.0.1220023.
- Campbell EA, Linton EA, Wolfe CD, Scraggs PR, Jones MT, Lowry PJ. Plasma corticotropin-releasing hormone concentrations during pregnancy and parturition. J Clin Endocrinol Metab. 1987 May;64(5):1054-9. doi: 10.1210/jcem-64-5-1054.
- Gold PW, Goodwin FK, Chrousos GP. Clinical and biochemical manifestations of depression. Relation to the neurobiology of stress (1). N Engl J Med. 1988 Aug 11;319(6):348-53. doi: 10.1056/NEJM198808113190606. No abstract available.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 960048
- 96-M-0048
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