Clinical Trial: Metformin and Congenital Nephrogenic Diabetes Insipidus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Emory University

Current Primary Outcome: Change in mean urine osmolality [ Time Frame: 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.


Original Primary Outcome:

  • Change in mean urine osmolality [ Time Frame: 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.
  • Change in mean urine volume [ Time Frame: 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.


Current Secondary Outcome: Change in mean urine volume [ Time Frame: 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.


Original Secondary Outcome:

Information By: Emory University

Dates:
Date Received: May 29, 2015
Date Started: September 2015
Date Completion: June 2017
Last Updated: October 31, 2016
Last Verified: October 2016