HyperlipidemiaNCT01099176
Effects of Hypolipemic Treatment on Adipokines
A study testing To compare monotherapies and combined therapy with each other in people with Hyperlipidemia and Impaired Fasting Glycemia, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Impaired Fasting Glycemia
- What is being tested?
- To compare monotherapies and combined therapy with each other
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 sitePoland
- Study dates
- May 2008to Sep 2009
- 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)
- Impaired fasting glycemia (glycemia 100-125mg/dl)
- 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 19Show fewer
- Moderate or severe hypertension
- Cancer in less than 5 years
- Chronic kidney disease (stage III-V)
- Liver failure
- Diabetes
- 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.
About this study
Official title: The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines
The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.
- Conditions
- Hyperlipidemia, Impaired Fasting Glycemia
- Being tested
- To compare monotherapies and combined therapy with each other
- Keywords
- hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare monotherapies and combined therapy with each otherDrug
Each patient received two tablets per day. Time interval between pills - 12 hours.
In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 10mg of Atorvastatin Receives: Drug: To compare monotherapies and combined therapy with each other |
| Fenofibrate | Experimental | 267mg of Fenofibrate Receives: Drug: To compare monotherapies and combined therapy with each other |
| Fenofibrate and atorvastatin | Experimental | 10mg of Atorvastatin and 267mg of fenofibrate Receives: Drug: To compare monotherapies and combined therapy with each other |
| Therapeutic Lifestyle Change | Placebo comparator | Placebo and Therapeutic Lifestyle Change Receives: Drug: To compare monotherapies and combined therapy with each other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipokines
Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.
Measured: Day 90
Secondary outcomes (3)
Proinflammatory cytokines
Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment
Measured: Day 30
Adipokines
Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.
Measured: Day 30
Proinflammatory cytokines
Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Scientific Research and Information Technology, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099176
- Sponsor's protocol ID
- Ministry of Science
- Status last verified
- Mar 2006
- First submitted
- 5 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines
- ClinicalTrials.gov ID
- NCT01099176
- Acronym / sponsor ID
- Ministry of Science
- Conditions
- Hyperlipidemia, Impaired Fasting Glycemia
- Keywords
- hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Ministry of Scientific Research and Information Technology, Poland
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 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 monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: To compare monotherapies and combined therapy with each other10mg of Atorvastatin |
| Fenofibrate | Experimental | Drug: To compare monotherapies and combined therapy with each other267mg of Fenofibrate |
| Fenofibrate and atorvastatin | Experimental | Drug: To compare monotherapies and combined therapy with each other10mg of Atorvastatin and 267mg of fenofibrate |
| Therapeutic Lifestyle Change | Placebo comparator | Drug: To compare monotherapies and combined therapy with each otherPlacebo and 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)
- Impaired fasting glycemia (glycemia 100-125mg/dl)
- For women:
- Menopause (>12 months)
Key exclusion criteria (19 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 |
|---|---|---|
| To compare monotherapies and combined therapy with each otherEach patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets | Drug | Atorvastatin, Fenofibrate, Fenofibrate and atorvastatin, Therapeutic Lifestyle Change |
Primary outcome
Adipokines
Time frame: Day 90
Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.
3 secondary outcomes
Proinflammatory cytokines
Time frame: Day 30
Adipokines
Time frame: Day 30
Proinflammatory cytokines
Time frame: Day 90
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 9 Apr 2010.
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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?
A study testing To compare monotherapies and combined therapy with each other in people with Hyperlipidemia and Impaired Fasting Glycemia, 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 19 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 9 Apr 2010. 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?
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?
Adipokines (time frame: Day 90). 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 Apr 2010.