Clinical trial NCT04932070: Berberine and Polycystic Ovary Syndrome
Official title: Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Berberine
Keywords: berberine
Polycystic Ovary Syndrome
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.


Eligibility criteria: Inclusion Criteria:

* normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
* newly detected Polycystic Ovary Syndrome

Exclusion Criteria:

* any concomitant medication
* presence of liver, renal and thyroid disease
* smoking
* drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Primary outcomes:
measure: Changes on insulin resistance
timeFrame: Changes from baseline insulin resistance at 8 weeks
Secondary outcomes:
measure: Changes on inflammation
timeFrame: Changes from baseline inflammation at 8 weeks
measure: Changes on inflammation
timeFrame: Changes from baseline inflammation at 8 weeks
measure: Changes on lipid profile
timeFrame: Changes from baseline lipid profile at 8 weeks
measure: Changes on Carbohydrate profile
timeFrame: Changes from baseline Carbohydrate profile at 8 weeks
measure: Changes on Carbohydrate profile
timeFrame: Changes from baseline Carbohydrate profile at 8 weeks
measure: Changes on Hormonal profile
timeFrame: Changes from baseline Hormonal profile at 8 weeks
measure: Changes on Hormonal profile
timeFrame: Changes from baseline Hormonal profile at 8 weeks
measure: Changes on Hormonal profile
timeFrame: Changes from baseline Hormonal profile at 8 weeks
measure: Changes on safety
timeFrame: Changes from baseline safety at 8 weeks
measure: Changes on safety
timeFrame: Changes from baseline safety at 8 weeks
measure: Changes on safety
timeFrame: Changes from baseline safety at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 8 weeks
measure: Changes on body composition
timeFrame: Changes from baseline body composition at 8 weeks
measure: Changes on acne assessment
timeFrame: Changes from baseline acne assessment at 8 weeks
measure: Changes on acne assessment
timeFrame: Changes from baseline acne assessment at 8 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References: