Clinical trial: The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers (NCT00001953)

Eligibility criteria:
Female gender only, ages 18 to 75.

        Patients should have documented primary Sjogren's syndrome as determined by protocol
        84-D-0056. The diagnosis of primary Sjogren's syndrome will be based on the presence of all
        three of the following:

        Salivary gland abnormalities;

        Lacrimal gland abnormalities;

        Serologic abnormalities.

        Controls should have no signs or symptoms of Sjogren's syndrome, and negative serologic
        testing reconfirmed within 2 weeks of the OGTT.

        Willingness to: a) participate in phase I and II of the protocol; b) follow the guidelines
        set to prepare for the OGTT; and c) modify current medical therapy if necessary.

        Must be able to comply with protocol procedures.

        No patients with "incomplete" Sjogren's syndrome, i.e., with less than three positive
        findings as described above.

        No presence of physical or mental conditions that may interfere with the protocol. These
        include the following diseases and conditions:

        (Present at time of phase I/II): significant disruption of sleep-wake pattern (i.e., less
        than 4 hours of continuous sleep, on the night before the OGTT only), BMI less than 18 or
        equal to/greater than 30, anemia with Hgb less than 10 gm/dl, use of tobacco or alcohol;

        (Within the past 6 weeks): acute weight change (greater than 5%), use of contraceptives
        -BCP-, Depoprovera or Norplant), irregular menstrual cycle, lactation, blood drawing in
        excess of 50 ml, use of recreational drugs, modification of estrogen replacement therapy;

        (Within the past 6 months): chronic pattern of weight change (greater than 10%), eating
        disorders, uncontrolled hypo/hyperthyroidism, breast cancer, lymphoma or other malignancy,
        pregnancy, treatment for depression, insulinoma, VIPoma, pheochromocytoma, atrophic
        gastritis, active tuberculosis or treatment for it;

        (A history of): HIV+, sarcoidosis, secondary Sjogren's syndrome, bleeding diathesis, organ
        transplant, severe neuroendocrine, renal, cardiovascular, pulmonary or gastrointestinal
        disease (e.g., renal insufficiency, unstable angina, heart failure, severe emphysema,
        Crohn's disease), diabetes mellitus, acromegaly and mental retardation.

        No contraindications to OGTT. These include:

        Hospital inpatient status, acute illness, immobilization, starvation, severe emotional
        distress within one week of the OGTT;

        Low carbohydrate diet (less than 150 g/day) for 3 days preceding the OGTT;

        Pregnancy;

        Therapy which impairs glucose tolerance: e.g., niacin, thiazide diuretics, phenytoin,
        excess thyroxine or psychotropic drugs within 1 month of phase I, oral contraceptives
        within 6 weeks of phase I, glucocorticoid treatment within the past 6 months (or one year
        if treatment lasted over 2 weeks), Beta blockers/agonists (e.g., terbutaline) within 2 days
        of phase I;

        Diabetes mellitus;

        Glucose intolerance.

        Subjects may not take medications that can affect somatostatin levels, such as
        antidepressants, benzodiazepines, neuromodulators (e.g., cholinergic, alpha/beta
        adrenergic), oral contraceptives (BCP), steroid hormones (with the exception of estrogen
        replacement therapy -ERT-, for which subjects will be matched), immunomodulators,
        anticonvulsants (e.g., carbamazepine), cimetidine -Tagamet® (Registered Trademark)-, herbal
        remedies (because of their variable substance content). Subjects may not take drugs
        affecting gastrin secretion: antacids (e.g., Maalox® (Registered Trademark), Mylanta®
        (Registered Trademark), H(2) receptor antagonists (e.g., famotidine -Pepcid® (Registered
        Trademark)-, ranitidine -Zantac® (Registered Trademark)-), cathecolamines, atropine,
        haloperidol. To become eligible, subjects should be able to safely discontinue these
        medications at least one month prior to phase I. Antacids, H(2) antagonists and
        neuromodulators (e.g., Salagen) may be discontinued 2 days prior to phase I.

        Patients cannot have take experimental drugs within 1 month of the beginning of the
        protocol.
Female
Accepts Healthy Volunteers



Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 1