The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

Sjogren's Syndrome Clinical Trial

Official title: Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogren's Syndrome and in Control Subjects

Status Completed

Clinical Trial Summary

This study aims to learn more about how the immune and hormonal systems function in patients with Sjogren's syndrome, a disease in which the immune system does not function properly. Adult nonpregnant females are invited to participate. Oral contraceptives may not be taken for 6 weeks before and during this study, so another form of birth control must be used, such as abstinence.

There will be two visits. At the first visit, a medical history and physical examination will be conducted, and blood and urine tests will be done. The total amount of blood drawn will be 10 tablespoons. This visit will last 3 hours. At the second visit, participants will have an oral glucose tolerance test. To prepare for it, they must be on a special diet for 3 days beforehand and keep a diary of eating, sleeping, and physical activities for those 3 days. A urine sample will be taken at the beginning of the visit. Subjects must then drink a very sweet carbonated cola. A small plastic tube will be placed into an arm vein. Blood will be drawn through this tube eight times over 3 hours. The total amount of blood drawn will be 17 tablespoons.

Only minor inconveniences are anticipated as a result of participating in this study. Risks from blood tests include soreness, bruising, and minor infection at the puncture site, and dizziness. The oral glucose tolerance test may cause temporary stomach bloating, headache, nausea, and vomiting.

Clinical Trial Description

Sjogren's syndrome is a chronic systemic disease that primarily affects the salivary and lacrimal glands and is characterized by lymphocytic tissue infiltration and auto-antibody production. The pathogenesis of Sjogren's syndrome is unknown. We hypothesize that reduced somatostatin activity is an important factor in promoting immune dysregulation in patients affected by Sjogren's syndrome. Somatostatin is a multifunctional peptide with potent immunomodulatory properties whose effects are reduced lymphocytic activity, reduced gastrointestinal secretions, activation of the hypothalamic-pituitary axis, anti-inflammatory, etc. As several findings in Sjogren's syndrome are opposite to those produced by somatostatin, it is logical to consider that the activity of this peptide is low in patients affected by this disease. The purpose of this study is to determine whether basal and stimulated plasma levels of somatostatin and its effects on the immune and endocrine systems differ between 16 patients affected by primary Sjogren's syndrome and 16 healthy control subjects. ;

Study Design

N/A

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

• NCT number: NCT00001953
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: N/A
• Start date: November 1999
• Completion date: December 2001