Metabolic Syndrome
Conditions
Brief summary
The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome; The secondary objectives of the trial are: * to evaluate the potential benefit after 3 months of therapy (by an interim analysis) * to evaluate the safety of FaseMETS
Detailed description
The trial is designed as a multicenter, open label, non-comparative, 6 months, pilot study. The primary objective is to evaluate the efficacy of FaseMetS ® administered for 6 months treatment combined with a health management plan in reducing the serum lipidemic profile (this includes total cholesterol, LDL cholesterol, HDL cholesterol, small density LDL particles, triglycerides, serum glucose, glycated haemoglobin (HBA1c), insulin, and pro-insulin, HOMA index, uric acid, body mass index (BMI), creatine phosphokinase) in patients diagnosed with Metabolic Syndrome and with mild to moderate Hypercholesterolemia. The secondary objectives are: * to evaluate the efficacy in reducing the serum lipidemic profile after a period of 3 months of FaseMetS ® ® treatment; * to evaluate the safety of FaseMetS ® treatment by recording AE/SAE (with particular regards for gastrointestinal symptoms); * improvement of blood clinical laboratory parameters; * improvement of weight control systolic blood pressure and diastolic blood pressure control
Interventions
DIETARY_SUPPLEMENTDaily administration: 2 tablets FaseMETS a day
Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome
Sponsors
Opera CRO, a TIGERMED Group Company
MDM S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* men or women * age \> 45 and ≤75 years * on cardiovascular disease prevention in clinical practice * written informed consent. * total cholesterol≥200 mg/dL * diagnosis of metabolic syndrome with three or more of the following: * Waist circumference: ≥89 cm for women and ≥102 cm for men or BMI≥25 Kg/m2; * Triglycerides level: ≥ 175 mg/dL or 1.7 mmol/L * HDL \<40 mg/dL (1.04 mmol/L) in men or \<50 mg/dL (1.3 mmol/L) in women * Blood sugar (fasting plasma glucose): ≥120 mg/dL (6.7 mmol/L) * Elevated blood pressure: systolic ≥ 130 and/or diastolic ≥ 85 mm Hg (antihypertensive drug treatment in a patient with a history of hypertension is an alternate indicator).
Exclusion criteria
* Pregnancy or lactation; * Patients at very high or low cardiovascular risk, having a calculated SCORE ≥10% or \<1% respectively * History of atrial fibrillation or atrial flutter * Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs * Patients with severe gastro-intestinal tract disorders with possible influence on drug absorption or electrolytes. * Patients with myeloproliferative disorders * Patients with severe chronic kidney disease (GFR 30 mL/min/ 1.73 m2), using Cockcroft's formula, with known liver disease or biliary obstructive disorders, chronic hepatitis, cirrhosis, with hyperkalemia or with ALAT or ASAT upper than 3 times the upper limit of normal laboratory range. * History of alcoholism or drug abuse. * Uncontrolled dysthyroidism, Cushing's syndrome, acromegalia, hyperparathyroidism. * Patients with HIV or taking drugs for HIV. * Patients taking statins or other dyslipidemic /hypolipidemic agents (drugs, food supplements, etc). * Patients taking antidiabetic drugs (i.e metformin, acarbose and/or others). * Patients unlikely to co-operate in the study or to comply well with treatment or with the study visits. * Participation in another study at the same time or within the preceding 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipidemic profile evaluated at 6 months | 6 months | laboratory test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipidemic profile evaluated at 3 months | 3 months | laboratory test |
| AE/SAE (with particular regards for gastrointestinal symptoms) | 6 months | * blood clinical laboratory parameters * physical examination including weight, systolic blood pressure and diastolic blood pressure |
Countries
Romania
Outcome results
None listed