Obesity, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Obesity
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.
Interventions
DRUGBerberine
1.5g daily for 3 month
DRUGPlacebo
placebo daily
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole body insulin action | 3 months | Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian androgen biosynthesis | 3 months |
| Hormonal profile | 3 months |
| Fasting lipid metabolic profile | 3 months |
| Oral glucose tolerance test (OGTT) | 3 months |
| Adverse events | 3 months |
| 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. | Three months |
| Renal and liver function tests | 3 months |
Countries
China
Contacts
Primary ContactXiaoke Wu, MD.PhD.
Backup ContactLihui Hou, MD.
Outcome results
None listed