Dynamics of Leptin and Endocrine Function

NCT00001543 | Completed

• 2 other identifiers: 96004896-M-0048
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Involutional Depression

Keywords

Major Depression; Metabolic Clearance Rate; Pulsatility; Adrenocorticotropic Hormone; Cortisol; Corticotropin Releasing Hormone Binding Protein; Pharmacokinetics; Half-Life; Bioavailability; Cushing's Syndrome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 2549150 BACKGROUND

• 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.

  PMID: 3494036 BACKGROUND

• 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.

  PMID: 3292920 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Cushing Syndrome

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 1, 1996
• Study Completion: June 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-06

Locations

US (1)