The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02026323
• Other study ID #: PCOSAir
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 27, 2013
• Last updated: September 5, 2014
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• acupuncture
acupuncture

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition(weight,height,waist circumference,hip circumference)		baseline,every month in treatment,the follow-up of 3 or 6 month	Yes
Primary	HOMA-IR		baseline,treat for 3 and 6 month ,3 or 6 month follow-up	Yes
Secondary	FSH	Determine FSH by electrogenerated chemiluminescence.	baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	LH		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	Androgen		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	Progesterone		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	Prolactin		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	Estradiol		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	dehydroepiandrosterone(sodium)sulfate		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	sex hormone binding globulin		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	c-peptide		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	Apoa1		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	ApoB		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	TC		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	TG		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	glycosylated hemoglobin		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes
Secondary	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	Yes
Secondary	Transvaginal ultrasound		baseline,up to 6 month,the follow-up of 3 or 6 month	Yes