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Metformin and Congenital Nephrogenic Diabetes Insipidus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460354
Recruitment Status : Terminated (Lack of effect in initial subjects)
First Posted : June 2, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Larry Greenbaum, MD, PhD, Emory University

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).

Condition or disease Intervention/treatment Phase
Diabetes Insipidus Drug: Metformin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
Study Start Date : September 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Metformin
Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally
Drug: Metformin
Metformin 500 mg pill dispensed once orally
Other Names:
  • Glumetza
  • Fortamet
  • Glucophage
  • Riomet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460354


Locations
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United States, Georgia
Childen's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Larry Greenbaum, MD, PhD Emory University
Principal Investigator: Titilayo Ilori, MD Emory University
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Responsible Party: Larry Greenbaum, MD, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02460354    
Other Study ID Numbers: IRB00077633
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Keywords provided by Larry Greenbaum, MD, PhD, Emory University:
Congenital nephrogenic diabetes insipidus
Additional relevant MeSH terms:
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Diabetes Insipidus
Diabetes Insipidus, Nephrogenic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs