Diabetes Mellitus, Type 2Phase 4NCT00262548
C-Reactive Protein (CRP) in Obese Diabetic Women
A Phase 4 study testing Rosuvastatin; improvement of lipid profile in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosuvastatin; improvement of lipid profile
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2005to not given
- Phase
- Phase 4
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal
- Diagnosed diabetes mellitus type 2
- Obese (body mass index [BMI] > 25 ≤ 30)
Who cannot join
- Fasting blood glucose ≥ 200 mg/dl
- CRP < 2 mg/L and > 10 mg/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women
The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosuvastatin; improvement of lipid profile
- Keywords
- Obesity, Menopause
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin; improvement of lipid profileDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients will be receiving rosuvastatin/placebo for 6 months
They will have baseline laboratory parameters taken such as glycemia
HbA1c (glycosylated hemoglobin), low-density lipoprotein cholesterol (LDL-C), computed tomography (CT), high-density lipoprotein cholesterol (HDL-C), C-reactive protein (CRP), and retaken every 3 months
Every month, patients will be evaluated at the clinic
All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.
Secondary outcomes (1)
Other variables will be: proinflammatory cytokines - tumor necrosis factor (TNF)-alpha, interleukin-6 (IL-6), IL-12, Th2/Th3 cytokines -IL-4, IL-10 and transforming growth factor beta (TGF-beta)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mexican National Institute of Public Health
- Investigators
- Astra Zeneca Mexico Medical Director, MD, Study director, AstraZenecaSimón Barquera Cervera, MD, Principal investigator, Mexican National Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262548
- Sponsor's protocol ID
- DM-CRESTOR-0001
- Other IDs
- D3560L00018
- Status last verified
- Aug 2007
- First submitted
- 26 Oct 2005
- Last updated
- 28 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women
- ClinicalTrials.gov ID
- NCT00262548
- Acronym / sponsor ID
- DM-CRESTOR-0001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Obesity, Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Mexican National Institute of Public Health
- Study start
- Oct 2005
- First posted
- 7 Dec 2005 (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.
The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Menopausal
- Diagnosed diabetes mellitus type 2
- Obese (body mass index [BMI] > 25 ≤ 30)
Key exclusion criteria (2 listed)
- Fasting blood glucose ≥ 200 mg/dl
- CRP < 2 mg/L and > 10 mg/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin; improvement of lipid profile | Drug | – |
Primary outcome
Patients will be receiving rosuvastatin/placebo for 6 months
They will have baseline laboratory parameters taken such as glycemia
HbA1c (glycosylated hemoglobin), low-density lipoprotein cholesterol (LDL-C), computed tomography (CT), high-density lipoprotein cholesterol (HDL-C), C-reactive protein (CRP), and retaken every 3 months
Every month, patients will be evaluated at the clinic
All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.
1 secondary outcome
Other variables will be: proinflammatory cytokines - tumor necrosis factor (TNF)-alpha, interleukin-6 (IL-6), IL-12, Th2/Th3 cytokines -IL-4, IL-10 and transforming growth factor beta (TGF-beta)
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 28 Aug 2007.
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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.
Astra Zeneca Mexico Medical Director, MD study director
AstraZeneca
Simón Barquera Cervera, MD principal investigator
Mexican National Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin; improvement of lipid profile in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Mexico.
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 3 inclusion and 2 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 28 Aug 2007. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patients will be receiving rosuvastatin/placebo for 6 months. The study lists 5 primary outcomes in all. 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 28 Aug 2007.