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Effects of Genistein in Postmenopausal Women With Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Ministry of Education, Universities and Research, Italy
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina
ClinicalTrials.gov Identifier:
NCT01664650
First received: August 7, 2012
Last updated: August 9, 2012
Last verified: August 2012

August 7, 2012
August 9, 2012
September 2008
November 2010   (final data collection date for primary outcome measure)
homeostasis model assessment for insulin resistance (HOMA-IR) [ Time Frame: change from baseline at 6 and 12 months ] [ Designated as safety issue: No ]
HOMA-IR was calculated using the following formula: fasting glucose (mg/dl) X fasting insulin (uIU/ml)/22.5.
Same as current
Complete list of historical versions of study NCT01664650 on ClinicalTrials.gov Archive Site
  • body mass index [ Time Frame: basal, 6 and 12 months ] [ Designated as safety issue: No ]
    The body mass index (BMI) is calculated by dividing the weight measured in kilograms by the square of the height measured in metres [i.e. BMI = Weight (kg)/ Height (m)]2.
  • Blood pressure [ Time Frame: basal, 6 and 12 months ] [ Designated as safety issue: No ]
    Three seated blood pressure measurements were taken on the right arm with a sphygmomanometer after the participant had been resting for at least 5 min. Blood pressure values were based on the average of the second and third measurements.
  • Metabolic variables [ Time Frame: basal, 6 and 12 months ] [ Designated as safety issue: No ]
    Fasting glucose and insulin were measured in serum collected after an overnight fast using routine methods. Total cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), and triglycerides were measured by using a routine enzymatic method, and the Low-Density Lipoprotein Cholesterol (LDL-C) level was calculated by using the Friedewald formula: [Total cholesterol (mg/dL) - High Density Lipoprotein-Cholesterol (HDL-C) (mg/dL) - triglycerides (mg/dL)/5].
  • Inflammatory markers [ Time Frame: basal, 6 and 12 months ] [ Designated as safety issue: No ]
    Serum visfatin, adiponectin, and homocysteine were measured by using an immunoenzymatic assay was measured by using an immunoenzymatic assay.
  • Adverse events [ Time Frame: basal, 6 and 12 months ] [ Designated as safety issue: Yes ]
    Participants were asked about symptoms at clinic visits every 6 months. Standard clinical evaluations and laboratory analyses, including hematologic, renal, and liver function tests, were done every 6 months. Endometrial thickness was evaluated by using ultrasonography at baseline, 6 months, and 1 year. The endometrial thickness was measured in the sagittal plane from 1 basal layer to the other. If the endometrial thickness was 8 mm or greater or if uterine bleeding occurred, hysteroscopy and endometrial biopsy were performed. All unfavorable and unintended clinical effects were considered adverse effects and were evaluated for severity, duration, seriousness, and relation to the study drug and outcome.
Same as current
Not Provided
Not Provided
 
Effects of Genistein in Postmenopausal Women With Metabolic Syndrome
Role of Genistein on Metabolic Syndrome in Post-menopausal Women

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metabolic Syndrome
  • Dietary Supplement: Genistein
  • Dietary Supplement: Placebo
  • Placebo Comparator: Lifestyle counseling
    Placebo tablets. All participants were counseled on an moderate hypocaloric, Mediterranean-style diet composed of 25% to 30% energy from fat, less than 10% energy from saturated fatty acids, 55% to 60% energy from carbohydrates, and 15% energy from protein, with a cholesterol intake less than 300 mg/d and fiber intake of 35 g/d or greater.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Genistein
    Genistein 54 mg/day in 2 tablets for 12 months. All participants were counseled on an moderate hypocaloric, Mediterranean-style diet composed of 25% to 30% energy from fat, less than 10% energy from saturated fatty acids, 55% to 60% energy from carbohydrates, and 15% energy from protein, with a cholesterol intake less than 300 mg/d and fiber intake of 35 g/d or greater.
    Intervention: Dietary Supplement: Genistein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2011
November 2010   (final data collection date for primary outcome measure)

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.
Female
49 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01664650
20073XZSR3_003
No
Francesco Squadrito, University of Messina
University of Messina
Ministry of Education, Universities and Research, Italy
Principal Investigator: Francesco Squadrito, MD University of Messina
University of Messina
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP