Corticosteroids and Hemoglobin A1C Levels in Diabetic Pat... | NCT01798420

Studies
Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation

NCT01798420

Sponsor

The Nazareth Hospital, Israel

Status

Completed

Last Update Posted

Feb 25, 2013Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Diabetes
Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 21, 2013

First Submission Date that Met QC Criteria

Feb 22, 2013

First Posted Date

Feb 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2013

Last Update Posted Date

Feb 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

George Habib, Head, Rheumatology clinic, Nzareth hospital, Nzareth, The Nazareth Hospital, IsraelPrincipal Investigator

Lead Sponsor

The Nazareth Hospital, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Measure	Description	Time Frame
Hemoglobin A1C LEVEL		3 MONTHS

Measure	Description	Time Frame
Glucose levels		3 months

Measure	Description	Time Frame
Weight		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with COPD exacerbation

Exclusion Criteria:

Patients treated with steroids during the previous 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients with COPD ecaxerbation who are admitted to the hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of medicine		Nzareth	Nazareth	16000	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided