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The RCT of Acupuncture on PCOS Combined With IR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02491333
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : March 21, 2022
Sponsor:
Collaborators:
The University of Hong Kong
Karolinska Institutet
Information provided by (Responsible Party):
Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:
The objectives of this randomized controlled trial are to compare insulin sensitivity following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Other: true acupuncture Other: sham acupuncture Drug: metformin Drug: Placebo metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture on Insulin Sensitivity of Women With Polycystic Ovary Syndrome and Insulin Resistance: a Randomized Controlled Trial
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: true acupuncture + placebo metformin

True acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.

True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.

Other: true acupuncture
True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

Drug: Placebo metformin
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
Other Name: placebo Dimethylbiguanide

Sham Comparator: sham acupuncture + placebo metformin

Sham acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.

Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month. Placement of needles is unlikely to affect ovulation and IR in women with PCOS.

Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.

Other: sham acupuncture
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

Drug: Placebo metformin
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
Other Name: placebo Dimethylbiguanide

Active Comparator: sham acupuncture + metformin

Sham acupuncture and metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.

Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.Placement of needles is unlikely to affect ovulation and IR in women with PCOS.

Metformin will be given at 0.5g/times, 3 times one day and for 4 month.

Other: sham acupuncture
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

Drug: metformin
Metformin will be given at 0.5g/times, 3 times one day and for 4 month.
Other Name: Dimethylbiguanide




Primary Outcome Measures :
  1. Changes of HOMA-IR [ Time Frame: Change from Baseline Systolic Blood Pressure at 4 months and 7 months ]

Secondary Outcome Measures :
  1. HOMA-B [ Time Frame: 4 months and 7 months ]
  2. AUCglu [ Time Frame: 4 months and 7 months ]
  3. Menstrual frequency [ Time Frame: 4 months and 7 months ]
  4. Body composition(a composite) [ Time Frame: 4 months and 7 months ]
    Weight, BMI, waist-to-hip circumference, FG and acne lesion counts

  5. Metabolic profile(a composite) [ Time Frame: 4 months and 7 months ]
    Glucose and insulin concentrations, C-peptide, HbA1c, TC, TG, HDL-C and LDL-C, ApoA1 and ApoB.

  6. Hormonal profile(a composite) [ Time Frame: 4 months and 7 months ]
    FSH, LH, T, SHBG and DHEAS

  7. Questionnaires(a composite) [ Time Frame: 4 months and 7 months ]
    SF-36, ChiQOL, sleeping questionnaires, IPAQ, PCOS-QOL, Zung SAS, Zung SDS questionnaires and the quantization table of TCM syndromes about PCOS

  8. Side effect profile [ Time Frame: 4 months and 7 months ]
  9. Expectation and credibility of treatment(questionnaire, 6 questions,4grades,0-24scores) [ Time Frame: 1 week and 4 months ]
  10. AUCins [ Time Frame: 4 months and 7 months ]
  11. Ovulation rate [ Time Frame: 4 months and 7 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese women aged from 18 to 40 years.
  2. BMI ≥18.5kg/m2.
  3. Confirmed diagnosis of PCOS according to modified Rotterdam criteria in 2003 including at least two of the following three features: ①Oligo-(an intermenstrual interval >35 days or <8 cycles in the past year), amenorrhea (an intermenstrual interval>90 days) and/or; ② polycystic ovarian morphology, i.e. presence of >12 antral follicles (≤ 9mm) and/or ovarian volume >10 ml on transvaginal scanning and/or; ③clinical and/or biochemical hyperandrogenism. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5 ; biochemical hyperandrogenism is total testosterone (T) > 2.6 nmol/l and free testosterone ≥6.0 pg/ml.
  4. Presence of IR as defined by the homeostatic model assessment (HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5). A value ≥ 2.14 will be considered to be indicative of IR.
  5. No immediate fertility wish and willingness to use barrier methods to contraception for one year.
  6. Willingness to sign the consent form.

Exclusion Criteria:

  1. Exclusion of other endocrine disorders:

    ① 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.

    ② Poorly controlled of Type I or Type II diabetes (defined as a HbA1c level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are alsoexcluded.

    • Cushing's syndrome (define as an archetype of MetS. High glucocorticoid levels lead to muscle, liver and adipocyte insulin resistance. 17-OHCS>55umol/24h or UFC>304nmol/24h) ④ Congenital adrenal hyperplasia (define as patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 17-OHP>10 ng/ml in ACTH 1-24 h excited test (after 60 min)) ⑤ Suspected androgen secreting adrenal or ovarian tumor.
  2. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months.
  3. Receiving acupuncture in the past 2 months.
  4. Within 6 weeks pregnancy.
  5. Post-abortion or postpartum within the past 6 weeks.
  6. Breastfeeding within the last 4 months.
  7. Not willing to give written consent to the study.
  8. Having a bariatric surgery procedure within the past 12 months or being in a period of acute weight loss.
  9. Additional exclusion criteria including:

    • Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.

      • Heart disease ③ Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma.

        • Patients enrolled into other studies that require medications. ⑤ Patients taking longer than a one month break during the protocol should not be enrolled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491333


Locations
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China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
The University of Hong Kong
Karolinska Institutet
Investigators
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Study Chair: Hongxia Ma The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Juan Li, PhD The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Maohua Lai, PhD The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Hua Liu, Master The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Wanting Wu, Master The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Ernest HY NG, PhD The University of Hong Kong
Study Director: Elisabet Stener-Victorin, PhD Karolinska Institutet
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hongxia Ma, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02491333    
Other Study ID Numbers: PCOSIRct
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Keywords provided by Hongxia Ma, The First Affiliated Hospital of Guangzhou Medical University:
polycystic ovary syndrome
acupuncture
insulin resistance
HOMA-IR
metformin
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs