Study Stopped
Lack of effect in initial subjects
Metformin and Congenital Nephrogenic Diabetes Insipidus
Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
1 other identifier
interventional
2
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 17, 2018
July 1, 2018
1.8 years
May 29, 2015
July 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 7 hours
Secondary Outcomes (1)
Change in mean urine volume
Baseline, 7 hours
Study Arms (1)
Metformin
EXPERIMENTALSubjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
Interventions
Metformin 500 mg pill dispensed once orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (3)
Childen's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Larry Greenbaum, MD, PhD
Emory University
- PRINCIPAL INVESTIGATOR
Titilayo Ilori, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 2, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 17, 2018
Record last verified: 2018-07