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
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