The effect of acupuncture or metformin for improvement of insulin sensitivity in women with Polycystic Ovary Syndrome

• Conditions: Polycystic ovary syndrome (PCOS) affects 10 to 15% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction. Women with PCOS have a 3 to 7-fold increased risk of developing type 2 diabetes (T2D).; MedDRA version: 18.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861; MedDRA version: 18.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-004250-18-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria – women with PCOS
1.Age 18 to 40 years
2.BMI =25 to =40 (=23 to =37.5 Chinese) given that 95% of all women with PCOS with a BMI 25 are insulin resistant (27, 28).
3.PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms (29): Clinical signs of hyperandrogenism (hirsutism or acne); oligo/amenorrhea; and/or polycystic ovaries (PCOS). Hirsutism is defined as a self-reported Ferriman-Gallwey (FG) score =8 (=5 Chinese) (30, 31). Acne is defined by a positive response to the question Do you have acne? Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea as <3 cycles per year. PCO is defined by transvaginal ultrasound with =12 follicles 2–9 mm and/or ovarian volume =10 ml in one or both ovaries.
4.Willing to sign the consent form.
Inclusion criteria – controls
Controls should have BMI >25 to <40, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG >4), evidence of PCO morphology on ultrasound.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 353
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for all women
1.Age >40
2.Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), androgen secreting tumors or suspected Cushing’s syndrome.
3.Having known kidney disease, autoimmune disorders or cancer.
4.Type I diabetes.
5.Pharmacological treatment (cortizon, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
6.Blood pressure >160 / 100 mmHg
7.Pregnancy or breastfeeding the last 6 months
8.Acupuncture last 2 months
9.Daily smoking and alcoholic intake
10.Language barrier or disabled person with reduced ability to understand information.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified