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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.
Last refreshed on: 12 December 2020
Main ID:  NCT02460354
Date of registration: 29/05/2015
Prospective Registration: Yes
Primary sponsor: Emory University
Public title: Metformin and Congenital Nephrogenic Diabetes Insipidus
Scientific title: Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
Date of first enrolment: September 2015
Target sample size: 2
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Larry Greenbaum, MD, PhD
Affiliation:  Emory University
Name:     Titilayo Ilori, MD
Affiliation:  Emory University
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Diabetes Insipidus
Drug: Metformin
Primary Outcome(s)
Change in mean urine osmolality [Time Frame: Baseline, 7 hours]
Secondary Outcome(s)
Change in mean urine volume [Time Frame: Baseline, 7 hours]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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