NCT01634035

Brief Summary

The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

June 3, 2010

Last Update Submit

July 2, 2012

Conditions

ESRD

Keywords

glycated hemoglobinmean plasma glucose

Outcome Measures

Primary Outcomes (1)

  • Measure levels of plasma blood glucose and HbA1c

    6 month intervals

Secondary Outcomes (1)

  • Measure ferritin, erythropoetin dose, reticulocytes count

    6 month intervals

Study Arms (1)

diabetic hemodialysis

all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months

Eligibility Criteria

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

all hemodialysis and diabetic population

You may qualify if:

  • Age\>18
  • Hemodialysis and diabetic
  • Lab data are available for more than 6 months

You may not qualify if:

  • Lab data not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Biospecimen

Retention: NONE RETAINED

review of previous blood tests

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • suzanne el-sayegh, md

    statenisland university hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2010

First Posted

July 6, 2012

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

US(1)