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The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. |
|
| Metformin+EQW | Experimental | Background therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. EQW: Participants will receive long-acting Exenatide once a week for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500 mg tid for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Patient's body weight was measured at the baseline and after 12 weeks of clinical trial |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who lost ≥5% of their body weight | 12 weeks | |
| Proportion of subjects who lost ≥ 10% of their body weight | 12 weeks | |
| Change in body mass index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Deng | Contact | 13167559763 | yanndeng@163.com | |
| Aiju Sun | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 1000730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40843067 | Derived | Xuesong D, Tao T, Weilu W, Wei X, Wei X, Yan D, Yanfang W, Ruilin M, Yingying G, Yue W, Perez-Lopez FR, Yang W. Combined metformin and exenatide versus only metformin treatments in polycystic ovary syndrome with abdominal obesity and network pharmacology of gene expression: evidence from a randomized clinical trial. Ther Adv Endocrinol Metab. 2025 Aug 19;16:20420188251355411. doi: 10.1177/20420188251355411. eCollection 2025. | |
| 34732660 |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010455 |
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| Exenatide 2 MG | Drug | Exenatide injection once weekly for 12 weeks |
|
|
| 12 weeks |
| Change in waist circumference(WC) | 12 weeks |
| Change in hip circumference (HC) | 12 weeks |
| Changes in lipid accumulation product(LAP) | LAP=(WC(cm)-58)×TG (mmol/L) | 12 weeks |
| Changes in Visceral obesity index(VAI) | VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l)) | 12 weeks |
| Changes in blood pressure | 12 weeks |
| Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT) | glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5 Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)] QUICKI= 1/Log[Glu0 (mU/ml) ×Ins0 (mmol/l)] HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5) MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)） ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0) | 12 weeks |
| Changes in total cholesterol (TC) | 12 weeks |
| Changes in serum triglyceride (TG) | 12 weeks |
| Changes in high-density lipoproteincholesterol (HDL-C) | 12 weeks |
| Changes in low-density lipoproteincholesterol (LDL-C) | 12 weeks |
| Changes in lipoprotein(a) | 12 weeks |
| Changes in apolipoprotein a1(ApoA1) | 12 weeks |
| Changes in apolipoprotein B(ApoB) | 12 weeks |
| Changes in free fatty acid (FFA) | 12 weeks |
| Changes in high sensitivity C reactive protein(hsCRP) | 12 weeks |
| Frequency of menstrual cycle | The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary. | 12 weeks |
| Changes in testosterone | 12 weeks |
| Changes in Dehydroepiandrosterone sulfate (DHEAS) | 12 weeks |
| Changes in Luteinizing Hormone (LH) | 12 weeks |
| Changes in follicle stimulating hormone(FSH) | 12 weeks |
| Changes in LH/FSH | 12 weeks |
| Changes in Acne severity score | This system divides the face, chest, and upper back into 6 areas: the forehead, right cheek,left cheek, nose, chin, and torso (chest and upper back combined). Each acne lesion is described and scored as a comedo (1 point), papule (2 points), pustule (3 points), or nodule (4 points); absence of an acne lesion in an area results in a score of 0 points. The local score for each anatomic area is determined by multiplying the score of the most severe lesion by an area factor (1 to 3), and the local scores of the 6 areas are then added together to obtain the total score. Acne severity is graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score N38 points) | 12 weeks |
| Changes in ovarian volume | 12 weeks |
| Changes in follicular number of 2-9mm in diameter | 12 weeks |
| Derived |
| Ma RL, Deng Y, Wang YF, Zhu SY, Ding XS, Sun AJ. Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome. Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |