Effects of Genistein in Postmenopausal Women With Metabolic Syndrome

Last updated: August 9, 2012
Sponsor: University of Messina
Overall Status: Completed

Phase

2/3

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01664650
20073XZSR3_003
  • Ages 49-67
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Post-menopausal satus

  • The presence of three or more of the five following criteria:

  1. waist circumference ≥88 cm;

  2. Triglycerides ≥150 mg/dl or on drug treatment for elevated triglycerides;

  3. high-density-lipoprotein (HDL) cholesterol <50 mg/dl or on drug treatment forreduced HDL-C;

  4. Fasting glucose ≥100 mg/dl or on drug treatment for elevated glucose;

  5. Blood pressure ≥130/85 mmHg or on antihypertensive drug treatment in a subjectwith a history of hypertension.

Exclusion

Exclusion Criteria:

  • clinical or laboratory evidence of confounding systemic diseases (e.g., chronic renalor hepatic failure, chronic inflammatory diseases)

  • cardiovascular disease (CVD) defined as documented myocardial infarction, ischaemicheart 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 standardECG performed in the 12 months preceding the study;

  • coagulopathy;

  • use of oral or transdermal estrogen, progestin, androgens, selective estrogen receptormodulators, or other steroids;

  • treatment in the preceding six months with polyunsaturated n-3 fatty acidssupplements, non steroidal anti-inflammatory drugs (NSAIDs) or steroids, that wouldinterfere with evaluation of the study medication;

  • smoking habit of more than 2 cigarettes daily.

Study Design

Total Participants: 120
Study Start date:
September 01, 2008
Estimated Completion Date:
January 31, 2011

Study 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.

Connect with a study center

  • University of Magnia Graecia

    Catanzaro,
    Italy

    Site Not Available

  • University of Messina

    Messina, 98123
    Italy

    Site Not Available

  • University of Palermo

    Palermo, 90129
    Italy

    Site Not Available

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