The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01101204

Acronym

MSF

Enrollment

200

Registered

2010-04-09

Start date

2012-07-31

Completion date

2012-12-31

Last updated

2012-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytokines, Diabetes, Dyslipidemia, Inflammation

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.

Interventions

DRUGMetformin 1000mg, simvastatin 10mg and fenofibrate 100mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 64 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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: 1. Interleukin 1 2. TNF alpha 3. Interleukin 6 4. Interleukin 10 5. hsCRP

Secondary

Measure	Time frame	Description
Insulin sensitivity	30 days	Assesed by HOMA (Homeostatic Model of Assessment)
Coagulation parameters	30 days	Assessed using: 1. Fibrinogen 2. PAI-1

Countries

Poland

Contacts

Primary ContactKrzysztof Labuzek, MD, PhD

lbuldak@gmail.com+48 32 252 39 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026