The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome

NCT02026323 | Unknown DMC

• 1 other identifier: PCOSAir
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  baseline,treat for 3 and 6 month ,3 or 6 month follow-up

Secondary Outcomes (16)

• FSH

  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

Other Outcomes (1)

• Body composition(weight,height,waist circumference,hip circumference)

  baseline,every month in treatment,the follow-up of 3 or 6 month

Study Arms (2)

acupuncture

EXPERIMENTAL

"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 2

EXPERIMENTAL

"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

Interventions

acupuncture OTHER

acupuncture

acupuncture; acupuncture 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years.
• BMI ≥18.5Kg/m2
• 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.
• 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.
• No desire of children and using barrier methods of contraception for 1 year.
• Willing to sign the consent form

You may not qualify if:

• 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.
• Patients with FSH levels \> 15 mIU/mL. A normal level within the last year is adequate for entry.
• 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.
• 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.
• Patients with suspected Cushing's syndrome.
• Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
• Pregnancy within the last 6 weeks.
• Post-abortion or postpartum within last 6 weeks.
• Breastfeeding within the last 6 months.
• Patients received Acupuncture treatment related to PCOS within the last 2 months.
• Patients who have undergone a bariatric surgery procedure in the recent past (\<12 months) and are in a period of acute weight loss.
• Patients with known congenital adrenal hyperplasia.
• Not willing to give written consent to the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The first affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (2)

• 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.

  PMID: 23676106 RESULT

• 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.

  PMID: 25941189 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hongxia HX Ma, Dorctor

  Study sponsor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: January 1, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

CN (1)