Clinical trial NCT01664650: Effects of Genistein in Postmenopausal Women With Metabolic Syndrome
Official title: Role of Genistein on Metabolic Syndrome in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Keywords: menopause
pre-diabetes
Lead sponsor: University of Messina
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Universities and Research, Italy
First posted: 2012-08-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 for reduced 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 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.

Primary outcomes:
measure: homeostasis model assessment for insulin resistance (HOMA-IR)
timeFrame: change from baseline at 6 and 12 months
Secondary outcomes:
measure: body mass index
timeFrame: basal, 6 and 12 months
measure: Blood pressure
timeFrame: basal, 6 and 12 months
measure: Metabolic variables
timeFrame: basal, 6 and 12 months
measure: Inflammatory markers
timeFrame: basal, 6 and 12 months
measure: Adverse events
timeFrame: basal, 6 and 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University of Magnia Graecia
city: Messina
country: Italy
facility: University of Messina
city: Palermo
country: Italy
facility: University of Palermo
Study officials:
affiliation: University of Messina
name: Francesco Squadrito, MD
role: PRINCIPAL_INVESTIGATOR
References: