Metformin and Congenital Nephrogenic Diabetes Insipidus



Status:Terminated
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:7/19/2018
Start Date:September 2015
End Date:June 2017

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

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).

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.

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
We found this trial at
3
sites
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, Georgia 30322
Principal Investigator: Larry Greenbaum, MD, PhD
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