Metformin and Congenital Nephrogenic Diabetes Insipidus

Diabetes Insipidus Clinical Trial

Official title:

Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02460354
• Other study ID #: IRB00077633
• Status: Terminated
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Diabetes Insipidus, Nephrogenic
• Diabetes Mellitus

Intervention

Drug:
• Metformin
Metformin 500 mg pill dispensed once orally

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean urine osmolality	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.	Baseline, 7 hours
Secondary	Change in mean urine volume	Urine volume is a measure of fluid balance. Change from baseline in average volume of urine collected from baseline to 7 hours.	Baseline, 7 hours