Metformin and Congenital Nephrogenic Diabetes Insipidus

Emory University

Status and phase

Terminated

Phase 1

Conditions

Diabetes Insipidus

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT02460354

IRB00077633

Details and patient eligibility

About

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).

Full 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.

Enrollment

2 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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