Role of Genistein on Metabolic Syndrome in Post-menopausal Women
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Messina
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- homeostasis model assessment for insulin resistance (HOMA-IR)
Study Overview
Brief Summary
The 15-25% of the population of developed countries suffers for metabolic syndrome. It is associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9 fold increase in developing type II diabetes. MS prevalence increases after the onset of menopause, because of estrogen deficiency. It is still not clear if menopause itself increases the risk of cardiovascular diseases in al women or only in those that develop MS. Many MS patients that show slight modification in cardiovascular and metabolic parameters are not generally pharmacologically treated since diabetes or alteration in the lipid profile are not evidenced. In this respect it is of importance to develop new therapeutic strategies to prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist activity.
Detailed Description
The investigators studied whether genistein may represent an efficacious and safe alternative for reducing vascular risk in postmenopausal women with metabolic syndrome. The clinical study was a randomized, double-blind, placebo-controlled study involving 150 patients with metabolic syndrome. After a 4-week stabilization on a standard fat-reduced diet, participants were randomly assigned to receive either phytoestrogen genistein (54 mg/day) or placebo for 6 months. At baseline and following treatment fasting plasma glucose, insulin, insulin resistance (HOMA-IR), lipid concentrations, plasma total homocysteine, leptin, adiponectin and visfatin were measured. Bioimpedentiometric and nutritional analysis, as well as a safety assessment of the endometrium and vagina were also performed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 49 Years to 67 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Post-menopausal satus
- •The presence of three or more of the five following criteria:
- •waist circumference ≥88 cm;
- •Triglycerides ≥150 mg/dl or on drug treatment for elevated triglycerides;
- •high-density-lipoprotein (HDL) cholesterol <50 mg/dl or on drug treatment for reduced HDL-C;
- •Fasting glucose ≥100 mg/dl or on drug treatment for elevated glucose;
- •Blood pressure ≥130/85 mmHg or on antihypertensive drug treatment in a subject with a history of hypertension.
Exclusion Criteria
- •clinical or laboratory evidence of confounding systemic diseases (e.g., chronic renal or hepatic failure, chronic inflammatory diseases)
- •cardiovascular disease (CVD) defined as documented myocardial infarction, ischaemic heart disease, coronary heart bypass, coronary angioplasty, cerebral thromboembolism, and peripheral amputations, or by Minnesota codes 1°1-3, 4°1-4, 5°1-3 at a standard ECG performed in the 12 months preceding the study;
- •coagulopathy;
- •use of oral or transdermal estrogen, progestin, androgens, selective estrogen receptor modulators, or other steroids;
- •treatment in the preceding six months with polyunsaturated n-3 fatty acids supplements, non steroidal anti-inflammatory drugs (NSAIDs) or steroids, that would interfere with evaluation of the study medication;
- •smoking habit of more than 2 cigarettes daily.
Outcomes
Primary Outcomes
homeostasis model assessment for insulin resistance (HOMA-IR)
Time Frame: change from baseline at 6 and 12 months
HOMA-IR was calculated using the following formula: fasting glucose (mg/dl) X fasting insulin (uIU/ml)/22.5.
Secondary Outcomes
- body mass index(basal, 6 and 12 months)
- Blood pressure(basal, 6 and 12 months)
- Metabolic variables(basal, 6 and 12 months)
- Inflammatory markers(basal, 6 and 12 months)
- Adverse events(basal, 6 and 12 months)
Investigators
Francesco Squadrito
Full Professor of Pharmacology
University of Messina