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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02460354 |
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Date of registration:
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29/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Metformin and Congenital Nephrogenic Diabetes Insipidus
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Scientific title:
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Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI) |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02460354 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Larry Greenbaum, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Name:
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Titilayo Ilori, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males with a documented mutation in the vasopressin type 2 receptor (V2R)
- Willing to provide consent and/or assent as appropriate
- Capable of providing urine samples as dictated by the protocol
Exclusion Criteria:
- Urinary incontinence
- Subjects who have heart disease, liver disease, diabetes, cancer, or other significant
disease other than Nephrogenic Diabetes Insipidus (NDI)
- Subjects with significant renal dysfunction (defined as a calculated glomerular
filtration rate (GFR) <80 ml/min/1.73 m^2)
- Subjects with acquired NDI
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Diabetes Insipidus
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Intervention(s)
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Drug: Metformin
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Primary Outcome(s)
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Change in mean urine osmolality
[Time Frame: Baseline, 7 hours]
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Secondary Outcome(s)
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Change in mean urine volume
[Time Frame: Baseline, 7 hours]
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Secondary ID(s)
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IRB00077633
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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