Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome

Insulin Resistance Clinical Trial

— PCOS-AcupIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457209
• Other study ID #: PCOS-AcupIR
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2011
• Last updated: January 20, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Research Council
• Study type: Interventional

Clinical Trial Summary

The 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 Polycystic Ovary Syndrome.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Acupuncture
Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands. Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks.

Locations

Country	Name	City	State
Sweden	Institute of Neuroscienncec and Physiology	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity	glucose disposal rate measured by euglycemic hyperinsulinemic clamp.	Day 1 and Week 5	Yes
Secondary	Change in insulin signaling (muscle and adipose tissue)	Western blot, RT-PCR	Day 1 and Week 5	Yes
Secondary	Change in health related quality of life	PCOSQ, SF36	Day 1 and Week 5	Yes
Secondary	Change in symptoms of anxiety and depression	CPRS-SA	Day 1 and Week 5	Yes
Secondary	Change in circulating sex steroids, adipokines, lipids and inflammatory markers	Mass spectrometry, ELISA	Day 1 and Week 5	Yes