Metformin and Congenital Nephrogenic Diabetes Insipidus

Phase 1

Terminated

• Conditions: Diabetes Insipidus
• Interventions: Drug: Metformin

• Registration Number: NCT02460354
• Lead Sponsor: Emory University

Brief 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).

Detailed Description

Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.

Study Timeline

• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Study Start: 2015-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally

Primary Outcome Measures

Name	Time	Method
Change in mean urine osmolality	Baseline, 7 hours	Urine osmolality is a measure of urine concentration. Urine osmolality will be measured using a Wescor vapor pressure osmometer. A normal range for urine osmolality is approximately 500-850 mOsm/kg water. Change is the difference in average osmolality from baseline to 7 hours.

Secondary Outcome Measures

Name	Time	Method
Change in mean urine volume	Baseline, 7 hours	Urine volume is a measure of fluid balance. Change from baseline in average volume of urine collected from baseline to 7 hours.

Trial Locations

Locations (3)

Childen's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI); 🇺🇸 Atlanta, Georgia, United States