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Home > "S" Clinical Trials Conditions > Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus  Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus
Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus
For Condition: Diabetes Insipidus,Diabetes Insipidus, Neurohypophyseal
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
Details: PROTOCOL OUTLINE: This project involves 2 clinical studies. Members of known kindreds participate in Study I; members of kindreds who have not been surveyed, genotyped, or phenotyped participate in Study II. In Study I, participants undergo clinical, hormonal, radiologic, and biochemical studies. Assessment on unrestricted fluid intake includes body weight, urine volume, osmolality, creatinine, sodium, potassium, urea, glucose, arginine-vasopressin (AVP), oxytocin, and aquaporin-II. Participants with diabetes insipidus (DI) undergo a standard fluid deprivation test; those without DI undergo standard water load and hypertonic saline testing. Previously untreated DI patients may be given intranasal or subcutaneous desmopressin or oral chlorpropamide (adults only) for 2 or 3 days. Magnetic resonance imaging of the pituitary-hypothalamic area is performed on all patients with and without gadolinium. Infants and children are studied annually for the first 5 years or until they develop DI. Affected adults are studied every 2-5 years. Unaffected adults are re-tested only if they subsequently report de novo symptoms suggestive of DI. In Study II, participants undergo similar genotype and phenotype testing. Kindreds demonstrating the familial neurohypophyseal diabetes insipidus phenotype and genotype are added to Study I. Kindreds found to have a different type of DI are directed into a companion protocol.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 6 Months/70 Years
Genders: Both
Protocol Entry Criteria: - Verified or suspected familial neurohypophyseal diabetes insipidus with or without an identified mutation of the vasopressin-neurophysin II gene Affected and unaffected members of kindreds entered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryRobertson, Study Chair, Northwestern University
Northwestern University Medical School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00048-0568; NU-568
Study Start Date: December 1995
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004363
Other Diabetes Insipidus, Neurohypophyseal Studies:
1. Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus
Related Studies:
Other Diabetes Insipidus, Neurohypophyseal Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus
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