MSF: The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

Sponsor

Medical University of Silesia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01101204

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

39.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Dyslipidemia Inflammation Cytokines	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: M1000 S10 F100 metformin 1000mg, fenofibrate 100mg and simvastatin 10mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M1000 S10 F267 metformin 1000mg, fenofibrate 267mg and simvastatin 10mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M1000 S40 F100 metformin 1000mg, fenofibrate 100mg and simvastatin 40mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M1000 S40 F267 metformin 1000mg, fenofibrate 267mg and simvastatin 40mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S10 F100 metformin 2500mg, fenofibrate 100mg and simvastatin 10mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S10 F267 metformin 2500mg, fenofibrate 267mg and simvastatin 10mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S40 F267 metformin 2500mg, fenofibrate 267mg and simvastatin 40mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S40 F100 metformin 2500mg, fenofibrate 100mg and simvastatin 40mg	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Placebo Comparator: Therapeutic Lifestyle Change Only therapeutic lifestyle change	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.

Outcome Measures

Primary Outcome Measures

Antiinflammatory effects of combined antidiabetic and hypolipemic treatment [30 days]
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

Secondary Outcome Measures

Insulin sensitivity [30 days]
Assesed by HOMA (Homeostatic Model of Assessment)
Coagulation parameters [30 days]
Assessed using: Fibrinogen PAI-1

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology	Katowice		Poland	40752

Sponsors and Collaborators

Medical University of Silesia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bogusław Okopień, MD PhD, Medical University of Silesia

ClinicalTrials.gov Identifier:

NCT01101204

Other Study ID Numbers:

First Posted:

Apr 9, 2010

Last Update Posted:

Jul 9, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2012