Clinical trial · Interventional

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

NCT02026323CI-TRIAL-00015553unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Insulin Resistance	—	UNRESOLVED	—
Polycystic Ovary Syndrome	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
acupuncture	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
acupuncture
description
"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.
interventionNames
1. Other: acupuncture
type
EXPERIMENTAL
label
acupuncture 2
description
"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.
interventionNames
1. Other: acupuncture

Primary outcomes (1)

measure
HOMA-IR

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years

Show eligibility criteria text

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.

References

Publications (2)

RESULTZheng 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. PMID 23676106
DERIVEDZheng 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. PMID 25941189

Registry

Dates and enrollment

Start: Jan 1, 2014
Primary completion: Oct 1, 2014
Completion: May 1, 2015
First posted: Jan 1, 2014
Last update posted: Sep 8, 2014
Enrollment: 112 (estimated)
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University OTHER

Data updated 22 days agoSource updated Sep 8, 2014source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.