Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
This study is currently recruiting participants.
Verified May 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
Heilongjiang University of Chinese Medicine
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01138930
First received: June 7, 2010
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Polycystic Ovary Syndrome Obesity |
Drug: Berberine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS |
Resource links provided by NLM:
Further study details as provided by Heilongjiang University of Chinese Medicine:
Primary Outcome Measures:
- Whole body insulin action [ Time Frame: 3 months ] [ Designated as safety issue: No ]Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
Secondary Outcome Measures:
- Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Ovarian androgen biosynthesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Hormonal profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Fasting lipid metabolic profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Renal and liver function tests [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment. [ Time Frame: Three months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Berberine |
Drug: Berberine
1.5g daily for 3 month
|
| Placebo Comparator: Placebo |
Drug: Placebo
placebo daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138930
Contacts
| Contact: Xiaoke Wu, MD.PhD. | 86-451-8213 0094 | xiaokewu2002@vip.sina.com |
| Contact: Lihui Hou, MD. | 86-451-8213 0094 | houlihui2007@sina.com |
Locations
| China, Guangdong | |
| Affiliated Hospital of Guangzhou Medical University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Hongxia Ma, MD | |
| Principal Investigator: Hongxia Ma, MD | |
| China, Heilongjiang | |
| Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine . | Recruiting |
| Harbin, Heilongjiang, China, 150040 | |
| Contact: Xiaoke Wu, MD.PhD. 86-451-8213 0094 xiaokewu2002@vip.sina.com | |
| First Affliated Hospital of Harbin Medical University | Recruiting |
| Harbin, Heilongjiang, China, 150001 | |
| Contact: Zhuoran Wang, MD | |
| Principal Investigator: Zhuoran Wang, MD | |
| Forth Affiliated Hospital of Harbin Medcal University | Recruiting |
| Harbin, Heilongjiang, China, 150001 | |
| Contact: Shiyu Han, MD | |
| Principal Investigator: Shiyu Han, MD | |
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 |
More Information
No publications provided
| Responsible Party: | Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01138930 History of Changes |
| Other Study ID Numbers: | berberine2010 |
| Study First Received: | June 7, 2010 |
| Last Updated: | May 8, 2013 |
| Health Authority: | China: Ministry of Health United States: Food and Drug Administration |
Keywords provided by Heilongjiang University of Chinese Medicine:
|
Polycystic Ovary Syndrome Obesity |
Additional relevant MeSH terms:
|
Obesity Polycystic Ovary Syndrome Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013