Terminé

Dynamics of Leptin and Endocrine Function

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Ce qui est collecté

Collecte de données

Qui peut participer

Maladies de la glande surrénale+5

+ Hyperfonctionnement corticosurrénalien

+ Troubles Mentaux

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Comment se déroule l'étude

Observationnel
Date de début : mars 1996
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Mental Health (NIMH)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 mars 1996

Date à laquelle le premier participant a commencé l'étude.

Our group has tested the hypothesis that the molecules involved in the neurobiology of the stress response are key elements in the pathophysiology, treatment, and medical consequences of major depressive disorder. Leptin is implicated in the regulation of adipose tissue, body weight and homeostasis. In the first three years of this protocol we accomplished the following: (1) discovered leptin pulsatility; (2) showed that is secreted in a highly organized manner in men and women; (3) showed for the first time in humans an inverse relation between rapid fluctuations in plasma leptin concentrations in healthy volunteers and those of adrenocorticotropic hormone (ACTH) and cortisol; (4) demonstrated a complex relation between the minute-to-minute dynamics of leptin and those of luteinizing hormone and estradiol; (5) showed a striking correlation between the 24-h dynamics of leptin and those of TSH and GH; (6) demonstrated highly significant correlation between hourly fluctuations of leptin levels and those of psychometric variables such as sadness, social withdrawal, and carbohydrate craving, and (7) showed that women produce twice as much leptin per secretory event than men. By studying patients with a leptin gene mutation we showed that at least one intact copy of the leptin gene is required for the regulation of TSH function and GH architecture in humans. These results indicate that leptin, a peripherally secreted molecule, appears to modulate the secretion of hypothalamic hormones. We have therefore proposed that hypothalamic neuroendocrine transduction, a key function of the CNS, may be regulated by leptin, a peripheral pulsatile signal of nutritional status. We would like to continue and expand our studies on the interactions of leptin, fat distribution, and the pituitary-adrenal axis in normal volunteers and also in patients with depression, because depression is characterized by alterations in food intake, body weight, and neuroendocrine function. Leptin profoundly affects the regulation of these three parameters. Leptin also increases insulin resistance, being therefore a risk factor for coronary artery disease, which is more prevalent and associated with higher mortality in depressed patients than in the general population. The data to be generated by this study will provide a better understanding of pathophysiology and medical consequences of major depression.

NCT00001543
Sponsor principalNational Institute of Mental Health (NIMH)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

230 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies de la glande surrénaleHyperfonctionnement corticosurrénalienTroubles MentauxTrouble DépressifMaladies du système endocrinienTroubles de l'humeurSyndrome de CushingTrouble dépressif majeur

Critères

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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

National Institute of Mental Health (NIMH)

Bethesda, United StatesOuvrir National Institute of Mental Health (NIMH) dans Google Maps
Terminé1 Centres d'Étude