Metformin and Congenital Nephrogenic Diabetes Insipidus

• Status: Terminated
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Arginine Vasopressin; Metformin

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