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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
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

June 7, 2010
May 8, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
Whole body insulin action [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
  • Glucose Disposal Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    measured by hyperinsulinemic euglycemic clamp
  • Measurement of sex steroids [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01138930 on ClinicalTrials.gov Archive Site
  • 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 ]
  • glucose levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fasting glucose levels and OGTT 2h glucose levels
  • Serum Triglycerides [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • HDL-c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • ovulation rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Obesity
  • Drug: Berberine
    1.5g daily for 3 month
  • Drug: Placebo
    placebo daily
  • Experimental: Berberine
    Intervention: Drug: Berberine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years
No
Contact: Xiaoke Wu, MD.PhD. 86-451-8213 0094 xiaokewu2002@vip.sina.com
Contact: Lihui Hou, MD. 86-451-8213 0094 houlihui2007@sina.com
China
 
NCT01138930
berberine2010
Yes
Xiaoke Wu, Heilongjiang University of Chinese Medicine
Heilongjiang University of Chinese Medicine
Not Provided
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
Heilongjiang University of Chinese Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP