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

Primary Purpose

Polycystic Ovary Syndrome, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Berberine
Placebo
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Obesity

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • First Affliated Hospital of Harbin Medical UniversityRecruiting
  • Forth Affiliated Hospital of Harbin Medcal UniversityRecruiting
  • Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Whole body insulin action
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2010
Last Updated
May 8, 2013
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01138930
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Obesity
Keywords
Polycystic Ovary Syndrome, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Berberine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Berberine
Intervention Description
1.5g daily for 3 month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo daily
Primary Outcome Measure Information:
Title
Whole body insulin action
Description
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Oral glucose tolerance test (OGTT)
Time Frame
3 months
Title
Ovarian androgen biosynthesis
Time Frame
3 months
Title
Hormonal profile
Time Frame
3 months
Title
Fasting lipid metabolic profile
Time Frame
3 months
Title
Renal and liver function tests
Time Frame
3 months
Title
Adverse events
Time Frame
3 months
Title
6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.
Time Frame
Three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoke Wu, MD.PhD.
Phone
86-451-8213 0094
Email
xiaokewu2002@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lihui Hou, MD.
Phone
86-451-8213 0094
Email
houlihui2007@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, MD.
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Ma, MD
First Name & Middle Initial & Last Name & Degree
Hongxia Ma, MD
Facility Name
First Affliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoran Wang, MD
First Name & Middle Initial & Last Name & Degree
Zhuoran Wang, MD
Facility Name
Forth Affiliated Hospital of Harbin Medcal University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyu Han, MD
First Name & Middle Initial & Last Name & Degree
Shiyu Han, MD
Facility Name
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, MD.PhD.
Phone
86-451-8213 0094
Email
xiaokewu2002@vip.sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27769284
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.
Results Reference
derived
PubMed Identifier
23866924
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.
Results Reference
derived

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

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