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

Sponsor

Heilongjiang University of Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT01138930

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Obesity	Drug: Berberine Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Berberine	Drug: Berberine 1.5g daily for 3 month
Placebo Comparator: Placebo	Drug: Placebo placebo daily

Arm

Intervention/Treatment

Experimental: Berberine

Drug: Berberine

1.5g daily for 3 month

Placebo Comparator: Placebo

Drug: Placebo

placebo daily

Outcome Measures

Primary Outcome Measures

Whole body insulin action [3 months]
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

Oral glucose tolerance test (OGTT) [3 months]
Ovarian androgen biosynthesis [3 months]
Hormonal profile [3 months]
Fasting lipid metabolic profile [3 months]
Renal and liver function tests [3 months]
Adverse events [3 months]
6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. [Three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria

Age of women between 18 and 35 years.
Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
Body mass index (BMI) equal to or greater than 23 kg/m2.
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

Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
Patients with known sever organ dysfunction or mental illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
2	First Affliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
3	Forth Affiliated Hospital of Harbin Medcal University	Harbin	Heilongjiang	China	150001
4	Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .	Harbin	Heilongjiang	China	150040

Sponsors and Collaborators

Heilongjiang University of Chinese Medicine

Investigators

Study Chair: Lihui Hou, MD., The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Study Chair: Xiaoke Wu, MD.PhD., The First Affliated Hospital,Heilongjiang University of Chinese Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine

ClinicalTrials.gov Identifier:

NCT01138930

Other Study ID Numbers:

berberine2010

First Posted:

Jun 8, 2010

Last Update Posted:

May 10, 2013

Last Verified:

May 1, 2013

Keywords provided by Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Polycystic Ovary Syndrome

Obesity

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of May 10, 2013