Diabetes Insipidus
Conditions
Keywords
Congenital nephrogenic diabetes insipidus
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.
Interventions
DRUGMetformin
Metformin 500 mg pill dispensed once orally
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed