DiabetesNCT01017848
Urine pH as a Predictor of Diabetes
An observational study of Diabetes, run by Northwell Health at 1 site in United States.
Trial summary
Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus involves insulin resistance. Thus, the investigators want to check if a simple cheap study like a urine analysis that can predict diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult inpatients, nondiabetic, no CKD, no urine infection, no UTO
Who may be able to join
- age > 18
Who cannot join
- diabetes
- CKD
- urine infection
- UTO
- bladder dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus involves insulin resistance. Thus, the investigators want to check if a simple cheap study like a urine analysis that can predict diabetes.
- Conditions
- Diabetes
- Keywords
- diabetes, urine pH, insulin resistance, metabolic syndrome, development of diabetes
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults, nondiabetics | adults who are nondiabetic, no CKD, no urinary tract infection, no bladder dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of diabetes using a predicting formula
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Suzanne El-Sayegh, Northwell Health
- Investigators
- Suzanne El-Sayegh, MD, Principal investigator, SIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017848
- Sponsor's protocol ID
- 09-031
- Status last verified
- Jun 2013
- First submitted
- 19 Nov 2009
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine pH as a Predictor of Diabetes
- ClinicalTrials.gov ID
- NCT01017848
- Acronym / sponsor ID
- 09-031
- Conditions
- Diabetes
- Keywords
- diabetes, urine pH, insulin resistance, metabolic syndrome, development of diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus involves insulin resistance. Thus, the investigators want to check if a simple cheap study like a urine analysis that can predict diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults, nondiabetics | – | –adults who are nondiabetic, no CKD, no urinary tract infection, no bladder dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult inpatients, nondiabetic, no CKD, no urine infection, no UTO
Key inclusion criteria (1 listed)
- age > 18
Key exclusion criteria (5 listed)
- diabetes
- CKD
- urine infection
- UTO
- bladder dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
development of diabetes using a predicting formula
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne El-Sayegh, MD principal investigator
SIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of diabetes using a predicting formula (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.