Back to resultsMetformin and Congenital Nephrogenic Diabetes Insipidus
Primary Purpose
Diabetes Insipidus
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Insipidus focused on measuring Congenital nephrogenic diabetes insipidus
Eligibility Criteria
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
Sites / Locations
- Childen's Healthcare of Atlanta
- Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
- Emory University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metformin
Arm Description
Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
Outcomes
Primary Outcome Measures
Change in mean urine osmolality
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 Outcome Measures
Change in mean urine volume
Urine volume is a measure of fluid balance. Change from baseline in average volume of urine collected from baseline to 7 hours.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02460354
Brief Title
Metformin and Congenital Nephrogenic Diabetes Insipidus
Official Title
Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of effect in initial subjects
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Insipidus
Keywords
Congenital nephrogenic diabetes insipidus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glumetza, Fortamet, Glucophage, Riomet
Intervention Description
Metformin 500 mg pill dispensed once orally
Primary Outcome Measure Information:
Title
Change in mean urine osmolality
Description
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.
Time Frame
Baseline, 7 hours
Secondary Outcome Measure Information:
Title
Change in mean urine volume
Description
Urine volume is a measure of fluid balance. Change from baseline in average volume of urine collected from baseline to 7 hours.
Time Frame
Baseline, 7 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Greenbaum, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Titilayo Ilori, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childen's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Metformin and Congenital Nephrogenic Diabetes Insipidus
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