Back to resultsThe Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome, Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The first affiliated hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
acupuncture
acupuncture 2
Arm 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.
"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.
Outcomes
Primary Outcome Measures
HOMA-IR
Secondary Outcome Measures
FSH
Determine FSH by electrogenerated chemiluminescence.
LH
Androgen
Progesterone
Prolactin
Estradiol
dehydroepiandrosterone(sodium)sulfate
sex hormone binding globulin
c-peptide
Apoa1
ApoB
TC
TG
glycosylated hemoglobin
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).
Transvaginal ultrasound
Full Information
NCT ID
NCT02026323
First Posted
December 27, 2013
Last Updated
September 5, 2014
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02026323
Brief Title
The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Official Title
Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture
Arm Type
Experimental
Arm 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.
Arm Title
acupuncture 2
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
acupuncture
Primary Outcome Measure Information:
Title
HOMA-IR
Time Frame
baseline,treat for 3 and 6 month ,3 or 6 month follow-up
Secondary Outcome Measure Information:
Title
FSH
Description
Determine FSH by electrogenerated chemiluminescence.
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
LH
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Androgen
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Progesterone
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Prolactin
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Estradiol
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
dehydroepiandrosterone(sodium)sulfate
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
sex hormone binding globulin
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
c-peptide
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Apoa1
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
ApoB
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
TC
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
TG
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
glycosylated hemoglobin
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Questionnaire investigation
Description
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).
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Title
Transvaginal ultrasound
Time Frame
baseline,up to 6 month,the follow-up of 3 or 6 month
Other Pre-specified Outcome Measures:
Title
Body composition(weight,height,waist circumference,hip circumference)
Time Frame
baseline,every month in treatment,the follow-up of 3 or 6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxia HX Ma, Dorctor
Organizational Affiliation
Study sponsor
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23676106
Citation
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.
Results Reference
result
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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The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
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