DiabetesNCT01798420
Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
An observational study of Diabetes and Chronic Obstructive Pulmonary Disease, run by The Nazareth Hospital, Israel at 1 site in Israel.
Trial summary
Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Chronic Obstructive Pulmonary Disease
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Oct 2012
- 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: Diabetic patients with COPD ecaxerbation who are admitted to the hospital
Who may be able to join
- Diabetic patients with COPD exacerbation
Who cannot join
- Patients treated with steroids during the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Corticosteroid Treatment on Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels
Read the 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.
- Conditions
- Diabetes, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Diabetes, steroids, Hemoglobin A1C DIFFERENCE
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Corticosteroid | Not described | |
| non-corticosteroid group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C LEVEL
Measured: 3 MONTHS
Secondary outcomes (1)
Glucose levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionOct 2012
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Nazareth Hospital, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Habib, The Nazareth Hospital, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798420
- Sponsor's protocol ID
- Hb-A1C-2012
- Status last verified
- Feb 2013
- First submitted
- 21 Feb 2013
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Corticosteroid Treatment on Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
- ClinicalTrials.gov ID
- NCT01798420
- Acronym / sponsor ID
- Hb-A1C-2012
- Conditions
- Diabetes, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Diabetes, steroids, Hemoglobin A1C DIFFERENCE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Nazareth Hospital, IsraelUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Feb 2013 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | – | – |
| non-corticosteroid group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with COPD ecaxerbation who are admitted to the hospital
Key inclusion criteria (1 listed)
- Diabetic patients with COPD exacerbation
Key exclusion criteria (1 listed)
- Patients treated with steroids during the previous 3 months
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
Hemoglobin A1C LEVEL
Time frame: 3 MONTHS
1 secondary outcome
Glucose levels
Time frame: 3 months
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 25 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Chronic Obstructive Pulmonary Disease, run by The Nazareth Hospital, Israel at 1 site in Israel.
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 1 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 25 Feb 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 Israel. 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?
Hemoglobin A1C LEVEL (time frame: 3 MONTHS). 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 25 Feb 2013.