Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome (PCOS-AcupIR)
Primary Purpose
Polycystic Ovary Syndrome, Insulin Resistance
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Insulin resistance, Acupuncture
Eligibility Criteria
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
- Age > 38 years
- Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
- Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
- 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.
- Blood pressure >160 / 100 mmHg
- Pregnancy or breastfeeding the last 6 months
- Acupuncture last 2 months
- Language barrier or disabled person with reduced ability to understand information.
Sites / Locations
- Institute of Neuroscienncec and Physiology
Outcomes
Primary Outcome Measures
Change in insulin sensitivity
glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
Secondary Outcome Measures
Change in insulin signaling (muscle and adipose tissue)
Western blot, RT-PCR
Change in health related quality of life
PCOSQ, SF36
Change in symptoms of anxiety and depression
CPRS-SA
Change in circulating sex steroids, adipokines, lipids and inflammatory markers
Mass spectrometry, ELISA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01457209
Brief Title
Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome
Acronym
PCOS-AcupIR
Official Title
Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
Keywords
PCOS, Insulin resistance, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
glucose disposal rate measured by euglycemic hyperinsulinemic clamp.
Time Frame
Day 1 and Week 5
Secondary Outcome Measure Information:
Title
Change in insulin signaling (muscle and adipose tissue)
Description
Western blot, RT-PCR
Time Frame
Day 1 and Week 5
Title
Change in health related quality of life
Description
PCOSQ, SF36
Time Frame
Day 1 and Week 5
Title
Change in symptoms of anxiety and depression
Description
CPRS-SA
Time Frame
Day 1 and Week 5
Title
Change in circulating sex steroids, adipokines, lipids and inflammatory markers
Description
Mass spectrometry, ELISA
Time Frame
Day 1 and Week 5
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Age > 38 years
Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
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.
Blood pressure >160 / 100 mmHg
Pregnancy or breastfeeding the last 6 months
Acupuncture last 2 months
Language barrier or disabled person with reduced ability to understand information.
Facility Information:
Facility Name
Institute of Neuroscienncec and Physiology
City
Göteborg
ZIP/Postal Code
43252
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32232327
Citation
Benrick A, Pillon NJ, Nilsson E, Lindgren E, Krook A, Ling C, Stener-Victorin E. Electroacupuncture Mimics Exercise-Induced Changes in Skeletal Muscle Gene Expression in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2020 Jun 1;105(6):2027-41. doi: 10.1210/clinem/dgaa165.
Results Reference
derived
PubMed Identifier
30113663
Citation
Nilsson E, Benrick A, Kokosar M, Krook A, Lindgren E, Kallman T, Martis MM, Hojlund K, Ling C, Stener-Victorin E. Transcriptional and Epigenetic Changes Influencing Skeletal Muscle Metabolism in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4465-4477. doi: 10.1210/jc.2018-00935.
Results Reference
derived
PubMed Identifier
25941189
Citation
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.
Results Reference
derived
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Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome
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