NCT01017848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

November 19, 2009

Last Update Submit

June 10, 2013

Conditions

Diabetes

Keywords

diabetesurine pHinsulin resistancemetabolic syndromedevelopment of diabetes

Outcome Measures

Primary Outcomes (1)

  • development of diabetes using a predicting formula

    10 years

Study Arms (1)

Adults, nondiabetics

adults who are nondiabetic, no CKD, no urinary tract infection, no bladder dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult inpatients, nondiabetic, no CKD, no urine infection, no UTO

You may qualify if:

  • age \> 18

You may not qualify if:

  • diabetes
  • CKD
  • urine infection
  • UTO
  • bladder dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin ResistanceMetabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Suzanne El-Sayegh, MD

    SIUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chair of Medicine

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 23, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)