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

NCT01138930 | Unknown DMC

• 1 other identifier: berberine2010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Polycystic Ovary Syndrome; Obesity

Keywords

Polycystic Ovary Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• Whole body insulin action

  Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp

  3 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Berberine

EXPERIMENTAL

Drug: Berberine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Berberine DRUG

1.5g daily for 3 month

Berberine

Placebo DRUG

placebo daily

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead

Study Sites (4)

Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

First Affliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Forth Affiliated Hospital of Harbin Medcal University

Harbin, Heilongjiang, 150001, China

RECRUITING

Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Harbin, Heilongjiang, 150040, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 27769284 DERIVED

• 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.

  PMID: 23866924 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

Berberine

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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 CHAIR

Central Study Contacts

Xiaoke Wu, MD.PhD.

CONTACT

86-451-8213 0094; xiaokewu2002@vip.sina.com

Lihui Hou, MD.

CONTACT

86-451-8213 0094; houlihui2007@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

CN (4)