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Trial Title:
A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome
NCT ID:
NCT06306417
Condition:
Polycystic Ovary Syndrome (PCOS)
Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Conditions: Keywords:
insulin resistance
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
lifestyle intervention
Description:
lifestyle intervention
Arm group label:
Experimental group
Arm group label:
control group
Intervention type:
Device
Intervention name:
acupuncture
Description:
acupuncture
Arm group label:
Experimental group
Intervention type:
Device
Intervention name:
Sham acupuncture
Description:
Sham acupuncture
Arm group label:
control group
Summary:
To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture
plus lifestyle management (treatment group), 2) placebo plus lifestyle management
(control group) in the treatment of insulin resistance in PCOS patients.
Detailed description:
A prospective, randomized controlled trial design was used to select women with
polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion
and exclusion criteria were randomly divided into an acupuncture plus lifestyle
intervention group (treatment group) and a placebo plus lifestyle intervention group
(control group). The differences in glucose metabolism and reproductive endocrinology
were compared between the two groups.
1. To verify the efficacy and safety of acupuncture intervention on insulin resistance
in PCOS;
2. To explore the effects of acupuncture on androgen and lipid levels, ovarian
function, reproductive dysfunction, mood and quality of life in women with PCOS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at
least two of the following three symptoms: (1) infrequent ovulation or anovulation;
(2) hyperandrogenism or clinical manifestations of high blood androgen; (3)
ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles
measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
Exclusion Criteria:
1. Exclusion of other endocrine disorders such as androgen secreting tumors, suspected
Cushing's syndrome and non-classic congenital adrenal hyperplasia
(17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
2. Type I diabetes or not well controlled type II diabetes
3. Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
4. Psychiatric diagnoses or using psychiatric medications including antidepressants
5. Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment
such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction
or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera
or similar within 6 months.
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University third hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Haolin Zhang, PHD
Phone:
+8615611963539
Email:
zoe@bjmu.edu.cn
Start date:
September 28, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06306417