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Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome (PCOS-AcupIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457209
First Posted: October 21, 2011
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Göteborg University
October 6, 2011
October 21, 2011
January 22, 2014
October 2011
December 2013   (Final data collection date for primary outcome measure)
Change in insulin sensitivity [ Time Frame: Day 1 and Week 5 ]
glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
Same as current
Complete list of historical versions of study NCT01457209 on ClinicalTrials.gov Archive Site
  • Change in insulin signaling (muscle and adipose tissue) [ Time Frame: Day 1 and Week 5 ]
    Western blot, RT-PCR
  • Change in health related quality of life [ Time Frame: Day 1 and Week 5 ]
    PCOSQ, SF36
  • Change in symptoms of anxiety and depression [ Time Frame: Day 1 and Week 5 ]
    CPRS-SA
  • Change in circulating sex steroids, adipokines, lipids and inflammatory markers [ Time Frame: Day 1 and Week 5 ]
    Mass spectrometry, ELISA
Same as current
Not Provided
Not Provided
 
Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome
Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Insulin Resistance
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.

Not Provided
Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01457209
PCOS-AcupIR
No
Not Provided
Not Provided
Göteborg University
Göteborg University
Not Provided
Not Provided
Göteborg University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP