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Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome


Phase 1
18 Years
38 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Insulin Resistance

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Trial Information

Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome


Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in
women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are
independent of body weight and worsen hyperandrogenism and ovulatory dysfunction.
Pharmacological treatments are symptom oriented and usually effective but have metabolic and
gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological
treatment strategies, as most women with PCOS require long-term treatment.

Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of
androgen excess and reverse insulin resistance and improve health related quality of life
and affective symptoms in overweight and obese women with and without PCOS.

The specific aim are designed to test the hypotheses that

1. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves
insulin sensitivity in overweight and obese women with and without PCOS

2. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key
signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and
adipose tissue in overweight and obese women with and without PCOS

3. Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related
quality of life and symptoms of anxiety and depression in overweight and obese women
with and without PCOS

Time frame of the study is 5-6 weeks. No long term follow up.


Inclusion Criteria:



- BMI > 25 to < 35 and

- Clinical signs of hyperandrogenism (hirsutism or acne) and

- At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified
polycystic ovaries

Controls should have BMI > 25 to < 35, regular cycles with 28 days ± 2 days, no signs of
hyperandrogenism.

Exclusion Criteria:

Exclusion criteria for all women

1. Age > 38 years

2. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin <
27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone <
3nmol/L), and androgen secreting tumors.

3. Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.

4. Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal
contraceptives, hormonal ovulation induction or other drugs judged by discretion of
investigator) within 12 wks accounts for all participants.

5. Blood pressure >160 / 100 mmHg

6. Pregnancy or breastfeeding the last 6 months

7. Acupuncture last 2 months

8. Language barrier or disabled person with reduced ability to understand information.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in insulin sensitivity

Outcome Description:

glucose disposal rate measured by euglycemic hyperinsulinemic clamp.

Outcome Time Frame:

Day 1 and Week 5

Safety Issue:

Yes

Authority:

Sweden: Regional Ethical Review Board

Study ID:

PCOS-AcupIR

NCT ID:

NCT01457209

Start Date:

October 2011

Completion Date:

June 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • PCOS
  • Insulin resistance
  • Acupuncture
  • Insulin Resistance
  • Polycystic Ovary Syndrome

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