NCT01798420

Brief Summary

Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

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

April 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

February 21, 2013

Last Update Submit

February 22, 2013

Conditions

DiabetesChronic Obstructive Pulmonary Disease

Keywords

COPDDiabetessteroidsHemoglobin A1C DIFFERENCE

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C LEVEL

    3 MONTHS

Secondary Outcomes (1)

  • Glucose levels

    3 months

Other Outcomes (1)

  • Weight

    3 months

Study Arms (2)

Corticosteroid

non-corticosteroid group

Eligibility Criteria

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

Diabetic patients with COPD ecaxerbation who are admitted to the hospital

You may qualify if:

  • Diabetic patients with COPD exacerbation

You may not qualify if:

  • Patients treated with steroids during the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medicine

Nzareth, Nazareth, 16000, Israel

Location

MeSH Terms

Conditions

Diabetes MellitusPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Rheumatology clinic, Nzareth hospital, Nzareth

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

IL(1)