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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02460354
Other study ID # IRB00077633
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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