The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome

Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study

Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve insulin sensitivity. Whether these findings can be translated into women with PCOS has not been investigated. Therefore, this study aims to evaluate whether acupuncture improves insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles improves insulin resistance, induces ovulation and improves quality of life.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Intervention / Treatment: Other: acupuncture

Detailed Description

This is a prospective observational study. A total of 112 women with PCOS and insulin resistance will be recruited and randomized into two groups according to their body mass index (BMI), i.e. normal weight (BMI=18.5-23Kg/m2) group and overweight or obese (BMI > 23Kg/m2) group1. The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. The primary outcome is changes in insulin sensitivity from baseline to after 6 months of acupuncture treatment measured by OGTT.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. BMI ≥18.5Kg/m2
3. Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligo-, amenorrhea (less than 8 cycles per year) or/clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
4. IR defined by the homeostatic model assessment (HOMA-IR: fasting insulin x fasting glucose/22.5) and 2.14 will be used as the cut off 33.
5. No desire of children and using barrier methods of contraception for 1 year.
6. Willing to sign the consent form

Exclusion Criteria:

1. With other endocrine disorders such as hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone <3nmol/L), and androgen secreting tumors.
2. Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry.
3. Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
4. Patients diagnosed with Type I diabetes, or Type I and Type II patients who receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
5. Patients with suspected Cushing's syndrome.
6. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
7. Pregnancy within the last 6 weeks.
8. Post-abortion or postpartum within last 6 weeks.
9. Breastfeeding within the last 6 months.
10. Patients received Acupuncture treatment related to PCOS within the last 2 months.
11. Patients who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss.
12. Patients with known congenital adrenal hyperplasia.
13. Not willing to give written consent to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: acupuncture; "Normal weight" group,the PCOS women with insulin resistance who are normal weight( BMI=18.5-23Kg/m2).The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.	Other: acupuncture; acupuncture
EXPERIMENTAL: acupuncture 2; "Over weight or obese" group ,the PCOS women with insulin resistance who are overweight or obese: BMI >23 Kg/m2.The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.	Other: acupuncture; acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HOMA-IR	baseline,treat for 3 and 6 month ,3 or 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FSH	Determine FSH by electrogenerated chemiluminescence.	baseline,up to 6 month,the follow-up of 3 or 6 month
LH		baseline,up to 6 month,the follow-up of 3 or 6 month
Androgen		baseline,up to 6 month,the follow-up of 3 or 6 month
Progesterone		baseline,up to 6 month,the follow-up of 3 or 6 month
Prolactin		baseline,up to 6 month,the follow-up of 3 or 6 month
Estradiol		baseline,up to 6 month,the follow-up of 3 or 6 month
dehydroepiandrosterone(sodium)sulfate		baseline,up to 6 month,the follow-up of 3 or 6 month
sex hormone binding globulin		baseline,up to 6 month,the follow-up of 3 or 6 month
c-peptide		baseline,up to 6 month,the follow-up of 3 or 6 month
Apoa1		baseline,up to 6 month,the follow-up of 3 or 6 month
ApoB		baseline,up to 6 month,the follow-up of 3 or 6 month
TC		baseline,up to 6 month,the follow-up of 3 or 6 month
TG		baseline,up to 6 month,the follow-up of 3 or 6 month
glycosylated hemoglobin		baseline,up to 6 month,the follow-up of 3 or 6 month
Questionnaire investigation	Health related quality of life, affective symptoms and personality: Will be determined by short form-36 (SF36), polycystic ovary syndrome questionnaire (PCOSQ),(generic and diagnosis-specific HRQL questionnaire),and the Chinese Quality of Life (ChQOL) ,and symptoms of anxiety and depression assessed by the Zung Self-Rating Anxiety Scale (Zung SAS) and Zung Self-Rating Depression Scale (Zung SDS).	baseline,up to 6 month,the follow-up of 3 or 6 month
Transvaginal ultrasound		baseline,up to 6 month,the follow-up of 3 or 6 month

Other Outcome Measures

Outcome Measure	Time Frame
Body composition(weight,height,waist circumference,hip circumference)	baseline,every month in treatment,the follow-up of 3 or 6 month

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Hongxia HX Ma, Dorctor, Study Sponsor

Publications and helpful links

General Publications

• Zheng YH, Wang XH, Lai MH, Yao H, Liu H, Ma HX. Effectiveness of abdominal acupuncture for patients with obesity-type polycystic ovary syndrome: a randomized controlled trial. J Altern Complement Med. 2013 Sep;19(9):740-5. doi: 10.1089/acm.2012.0429. Epub 2013 May 15.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): October 1, 2014
• Study Completion (ANTICIPATED): May 1, 2015

Study Registration Dates

• First Submitted: December 27, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: PCOSAir