The RCT of Acupuncture on PCOS Combined With IR

NCT02491333 | Completed Phase 3 DMC

• 1 other identifier: PCOSIRct
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Keywords

polycystic ovary syndrome; acupuncture; insulin resistance; HOMA-IR; metformin

Outcome Measures

Primary Outcomes (1)

• Changes of HOMA-IR

  Change from Baseline Systolic Blood Pressure at 4 months and 7 months

Secondary Outcomes (11)

• HOMA-B

  4 months and 7 months

• AUCglu

  4 months and 7 months

• Menstrual frequency

  4 months and 7 months

• Body composition（a composite）

  4 months and 7 months

• Metabolic profile（a composite）

  4 months and 7 months

Study Arms (3)

true acupuncture + placebo metformin

EXPERIMENTAL

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; Drug: Placebo metformin

sham acupuncture + placebo metformin

SHAM COMPARATOR

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; Drug: Placebo metformin

sham acupuncture + metformin

ACTIVE COMPARATOR

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; Drug: metformin

Interventions

true acupuncture OTHER

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.

true acupuncture + placebo metformin

sham acupuncture OTHER

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.

sham acupuncture + metformin; sham acupuncture + placebo metformin

metformin DRUG

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

Also known as: Dimethylbiguanide

sham acupuncture + metformin

Placebo metformin DRUG

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

Also known as: placebo Dimethylbiguanide

sham acupuncture + placebo metformin; true acupuncture + placebo metformin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese women aged from 18 to 40 years.
• BMI ≥18.5kg/m2.
• 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.
• 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.
• No immediate fertility wish and willingness to use barrier methods to contraception for one year.
• Willingness to sign the consent form.

You may not qualify if:

• 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.
• Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months.
• Receiving acupuncture in the past 2 months.
• Within 6 weeks pregnancy.
• Post-abortion or postpartum within the past 6 weeks.
• Breastfeeding within the last 4 months.
• Not willing to give written consent to the study.
• Having a bariatric surgery procedure within the past 12 months or being in a period of acute weight loss.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• The University of Hong Kong: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (39)

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MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Metformin

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)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hongxia Ma

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Elisabet Stener-Victorin, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

CN (1)