Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001953
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
The Functioning of Immune and Hormonal Systems in Patients With Sjogrens Syndrome and in Healthy Volunteers
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogrens Syndrome and in Control Subjects
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to learn more about how the immune and hormonal systems function in patients with Sjogrens 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
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
Detailed Description:
Sjogrens 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 Sjogrens syndrome is unknown We hypothesize that reduced somatostatin activity is an important factor in promoting immune dysregulation in patients affected by Sjogrens 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 Sjogrens 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 Sjogrens syndrome and 16 healthy control subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0022 | None | None | None |