Clinical trial NCT01138930: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
Official title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Keywords: Polycystic Ovary Syndrome
Obesity
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Whole body insulin action
timeFrame: 3 months
Secondary outcomes:
measure: Oral glucose tolerance test (OGTT)
timeFrame: 3 months
measure: Ovarian androgen biosynthesis
timeFrame: 3 months
measure: Hormonal profile
timeFrame: 3 months
measure: Fasting lipid metabolic profile
timeFrame: 3 months
measure: Renal and liver function tests
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
measure: 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.
timeFrame: Three months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Harbin
country: China
facility: First Affliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Forth Affiliated Hospital of Harbin Medcal University
state: Heilongjiang
city: Harbin
country: China
facility: Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
state: Heilongjiang
Study officials:
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
name: Lihui Hou, MD.
role: STUDY_CHAIR
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine
name: Xiaoke Wu, MD.PhD.
role: STUDY_CHAIR
References:
citation: Zhang Y, Sun J, Zhang YJ, Chai QY, Zhang K, Ma HL, Wu XK, Liu JP. The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. Trials. 2016 Oct 21;17(1):512. doi: 10.1186/s13063-016-1633-5.
citation: Li Y, Ma H, Zhang Y, Kuang H, Ng EH, Hou L, Wu X. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial. Trials. 2013 Jul 18;14:226. doi: 10.1186/1745-6215-14-226.