The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

Diabetes Clinical Trial

— MSF  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01101204
• Other study ID #: MSF
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2010
• Last updated: July 5, 2012
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Medical University of Silesia
• Contact: Krzysztof Labuzek, MD, PhD
• Phone: +48 32 252 39 02
• Email: lbuldak[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cytokines
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Inflammation

Intervention

Drug:
• Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.

Locations

Country	Name	City	State
Poland	Department of Clinical Pharmacology	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	Yes
Secondary	Insulin sensitivity	Assesed by HOMA (Homeostatic Model of Assessment)	30 days	Yes
Secondary	Coagulation parameters	Assessed using: Fibrinogen; PAI-1	30 days	Yes