DiabetesMSFNCT01101204
The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
A study testing Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg in people with Diabetes and Dyslipidemia, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Dyslipidemia, Inflammation
- What is being tested?
- Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2012to Dec 2012
- Phase
- Interventional
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (35-64yr)
- Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl)
- Type 2 Diabetes
- For women:
- Menopause (>12 months)
- Post hysterectomy
- Mechanical contraception
- Obtained informed consent
Who cannot join
- Secondary hyperlipidemia
- Morbid obesity (BMI>40kg/m2)
- Alcohol or drug abuse
- Acute or chronic inflammation
- Congestive Heart Failure (NYHA III or IV)
- Unstable Ischaemic Heart Disease
Show all 18Show fewer
- Moderate or severe hypertension
- Cancer in less than 5 years
- Chronic kidney disease (stage III-V)
- Liver failure
- Oral contraception
- Not compliant patient
- Laboratory results:
- alanine transferase (>3xULN)
- creatine kinase (>5xULN)
- haemoglobin (<10/dl)
- PLT (<100G/l)
- WBC (<3,5G/l or >10G/l)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Clinical Pharmacology
Katowice, Katowice, 40752
Krzysztof Labuzek, MD, PhD, +48 32 252 39 02, lbuldak@gmail.com
Łukasz Bułdak, MD
About this study
Official title: Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.
- Conditions
- Diabetes, Dyslipidemia, Inflammation, Cytokines
- Being tested
- Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgDrug
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
| Study group | Role | What they receive |
|---|---|---|
| M1000 S10 F100 | Active comparator | metformin 1000mg, fenofibrate 100mg and simvastatin 10mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M1000 S10 F267 | Active comparator | metformin 1000mg, fenofibrate 267mg and simvastatin 10mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M1000 S40 F100 | Active comparator | metformin 1000mg, fenofibrate 100mg and simvastatin 40mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M1000 S40 F267 | Active comparator | metformin 1000mg, fenofibrate 267mg and simvastatin 40mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M2500 S10 F100 | Active comparator | metformin 2500mg, fenofibrate 100mg and simvastatin 10mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M2500 S10 F267 | Active comparator | metformin 2500mg, fenofibrate 267mg and simvastatin 10mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M2500 S40 F267 | Active comparator | metformin 2500mg, fenofibrate 267mg and simvastatin 40mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| M2500 S40 F100 | Active comparator | metformin 2500mg, fenofibrate 100mg and simvastatin 40mg Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
| Therapeutic Lifestyle Change | Placebo comparator | Only therapeutic lifestyle change Receives: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines:
- Interleukin 1
- TNF alpha
- Interleukin 6
- Interleukin 10
- hsCRP
Measured: 30 days
Secondary outcomes (2)
Insulin sensitivity
Assesed by HOMA (Homeostatic Model of Assessment)
Measured: 30 days
Coagulation parameters
Assessed using:
- Fibrinogen
- PAI-1
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startJul 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bogusław Okopień, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101204
- Sponsor's protocol ID
- MSF
- Acronym
- MSF
- Status last verified
- Jul 2012
- First submitted
- 7 Apr 2010
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT01101204
- Acronym / sponsor ID
- MSF / MSF
- Conditions
- Diabetes, Dyslipidemia, Inflammation, Cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Apr 2010 (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 study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| M1000 S10 F100 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 1000mg, fenofibrate 100mg and simvastatin 10mg |
| M1000 S10 F267 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 1000mg, fenofibrate 267mg and simvastatin 10mg |
| M1000 S40 F100 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 1000mg, fenofibrate 100mg and simvastatin 40mg |
| M1000 S40 F267 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 1000mg, fenofibrate 267mg and simvastatin 40mg |
| M2500 S10 F100 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 2500mg, fenofibrate 100mg and simvastatin 10mg |
| M2500 S10 F267 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 2500mg, fenofibrate 267mg and simvastatin 10mg |
| M2500 S40 F267 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 2500mg, fenofibrate 267mg and simvastatin 40mg |
| M2500 S40 F100 | Active comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgmetformin 2500mg, fenofibrate 100mg and simvastatin 40mg |
| Therapeutic Lifestyle Change | Placebo comparator | Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgOnly therapeutic lifestyle change |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age (35-64yr)
- Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl)
- Type 2 Diabetes
- For women:
- Menopause (>12 months)
Key exclusion criteria (18 listed)
- Secondary hyperlipidemia
- Morbid obesity (BMI>40kg/m2)
- Alcohol or drug abuse
- Acute or chronic inflammation
- Congestive Heart Failure (NYHA III or IV)
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 |
|---|---|---|
| Metformin 1000mg, simvastatin 10mg and fenofibrate 100mgPatient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg. | Drug | M1000 S10 F100, M1000 S10 F267, M1000 S40 F100, M1000 S40 F267, M2500 S10 F100, M2500 S10 F267, M2500 S40 F100, M2500 S40 F267, Therapeutic Lifestyle Change |
Primary outcome
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
Time frame: 30 days
As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines: 1. Interleukin 1 2. TNF alpha 3. Interleukin 6 4. Interleukin 10 5. hsCRP
2 secondary outcomes
Insulin sensitivity
Time frame: 30 days
Coagulation parameters
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg in people with Diabetes and Dyslipidemia, run by Medical University of Silesia at 1 site in Poland.
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 8 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 9 Jul 2012. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Labuzek, MD, PhD (+48 32 252 39 02, lbuldak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment (time frame: 30 days). 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 9 Jul 2012.