- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02460354
Metformin and Congenital Nephrogenic Diabetes Insipidus
July 15, 2018 updated by: Larry Greenbaum, MD, PhD, Emory University
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30322
- Childen's Healthcare of Atlanta
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
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Metformin 500 mg pill dispensed once orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 7 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 7 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Larry Greenbaum, MD, PhD, Emory University
- Principal Investigator: Titilayo Ilori, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
May 29, 2015
First Submitted That Met QC Criteria
May 29, 2015
First Posted (Estimate)
June 2, 2015
Study Record Updates
Last Update Posted (Actual)
July 17, 2018
Last Update Submitted That Met QC Criteria
July 15, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00077633
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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