Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Obesity Clinical Trial

Official title:

Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01138930
• Other study ID #: berberine2010
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: May 8, 2013
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2013
• Source: Heilongjiang University of Chinese Medicine
• Contact: Xiaoke Wu, MD.PhD.
• Phone: 86-451-8213 0094
• Email: xiaokewu2002[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria

1. Age of women between 18 and 35 years.

2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.

3. Body mass index (BMI) equal to or greater than 23 kg/m2.

4. With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of =12 antral follicles (=9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score =5.

Exclusion criteria are

1. Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.

2. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome

3. Patients with known sever organ dysfunction or mental illness.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome

Intervention

Drug:
• Berberine
1.5g daily for 3 month
• Placebo
placebo daily

Locations

Country	Name	City	State
China	Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .	Harbin	Heilongjiang
China	First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Forth Affiliated Hospital of Harbin Medcal University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body insulin action	Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp	3 months	No
Secondary	Oral glucose tolerance test (OGTT)		3 months	No
Secondary	Ovarian androgen biosynthesis		3 months	No
Secondary	Hormonal profile		3 months	No
Secondary	Fasting lipid metabolic profile		3 months	No
Secondary	Renal and liver function tests		3 months	No
Secondary	Adverse events		3 months	No
Secondary	6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.		Three months	No