The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00001953|
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : March 4, 2008
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||32 participants|
|Official Title:||Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogren's Syndrome and in Control Subjects|
|Study Start Date :||November 1999|
|Estimated Study Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001953
|United States, Maryland|
|National Institute of Dental And Craniofacial Research (NIDCR)|
|Bethesda, Maryland, United States, 20892|