Current partner codePEPTIDESDE
NCT03151005·Phase 4·INTERVENTIONAL

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Status

Completed

Phase

Phase 4

Enrollment

70

Locations

1

Results

Posted

Publications

12

Study summary

What the protocol is testing.

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Full detailed description

Groups: Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy. Regular treatment: Metformin-Oral Contraceptive(OC) Therapy. Time Point: Initial treatment; Post-treatment (4w); Post-treatment (8w); Post-treatment (12w); Assess reproductive functions and cardiovascular risk factors.

Interventions

Treatment arms and agents.

DRUG

Metformin-GLP-1 Receptor Agonist

metformin oral with exenatide/liraglutide subcutaneous injection.

DRUG

Metformin-Oral Contraceptive(OC)

metformin with Diane 35 oral intake.

Timeline

From registration to results.

  1. First posted

    May 12, 2017

  2. Study start

    Jul 1, 2017

  3. Primary completion

    Apr 1, 2021

  4. Study completion

    Apr 23, 2021

  5. Results posted

    Dec 4, 2023

  6. Registry updated

    Dec 4, 2023

Outcomes

What the study measures.

Primary outcomes

Assessment of Reproductive Functions

Time frame · 12 weeks

Concentration of LH was measured in mIU/ml.

Secondary outcomes

Basic Vital Signs

Time frame · 12 weeks

Weight and height will be combined to report BMI in kg/m\^2.

Assessment of Liver Function

Time frame · 12 weeks

Alanine transaminase was measured in IU/L.

Assessment of Blood Pressure

Time frame · 12 weeks

Systolic blood pressure was measured in mmHg.

Assessment of Reproductive Function

Time frame · 12 weeks

Changes in testosterone levels were measured

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism. * Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks. * Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese \[body mass index (BMI) \>=24 kg/m2 or waistline\>=85cm \]. * All subjects had normal thyroid-stimulating hormone and prolactin levels. Exclusion Criteria: * smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions. * age below 18 yr or over 50 yr. * postmenopausal. * uncontrolled hypertension (blood pressure \>=160/100 mm Hg). * preexisting OPs or GLP-1 agonists supplementation * alcohol intake greater than 20 g/d, or pregnancy. * signs of liver or renal failure or active liver disease (ALT \> 2.5× the upper limit of normal values). * PLT\<60\*10\^9/L,Hb\<100g/L, smoking, alcohol use. * The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The Second Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Publications

Results and literature.

PMID 28646699Macut D, Bjekic-Macut J, Rahelic D, Doknic M. Insulin and the polycystic ovary syndrome. Diabetes Res Clin Pract. 2017 Aug;130:163-170. doi: 10.1016/j.diabres.2017.06.011. Epub 2017 Jun 12.PMID 12046553Zhou BF; Cooperative Meta-Analysis Group of the Working Group on Obesity in China. Predictive values of body mass index and waist circumference for risk factors of certain related diseases in Chinese adults--study on optimal cut-off points of body mass index and waist circumference in Chinese adults. Biomed Environ Sci. 2002 Mar;15(1):83-96.PMID 24389146Barthelmess EK, Naz RK. Polycystic ovary syndrome: current status and future perspective. Front Biosci (Elite Ed). 2014 Jan 1;6(1):104-19. doi: 10.2741/e695.PMID 26426951Dumesic DA, Oberfield SE, Stener-Victorin E, Marshall JC, Laven JS, Legro RS. Scientific Statement on the Diagnostic Criteria, Epidemiology, Pathophysiology, and Molecular Genetics of Polycystic Ovary Syndrome. Endocr Rev. 2015 Oct;36(5):487-525. doi: 10.1210/er.2015-1018.PMID 14688154Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.PMID 22777527Yildiz BO, Bozdag G, Yapici Z, Esinler I, Yarali H. Prevalence, phenotype and cardiometabolic risk of polycystic ovary syndrome under different diagnostic criteria. Hum Reprod. 2012 Oct;27(10):3067-73. doi: 10.1093/humrep/des232. Epub 2012 Jul 9.PMID 20471009Farrell K, Antoni MH. Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions. Fertil Steril. 2010 Oct;94(5):1565-74. doi: 10.1016/j.fertnstert.2010.03.081. Epub 2010 May 14.PMID 29569621Escobar-Morreale HF. Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment. Nat Rev Endocrinol. 2018 May;14(5):270-284. doi: 10.1038/nrendo.2018.24. Epub 2018 Mar 23.PMID 28463030Ruan X, Kubba A, Aguilar A, Mueck AO. Use of cyproterone acetate/ethinylestradiol in polycystic ovary syndrome: rationale and practical aspects. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):183-190. doi: 10.1080/13625187.2017.1317735. Epub 2017 May 2.PMID 28860713Wang YW, He SJ, Feng X, Cheng J, Luo YT, Tian L, Huang Q. Metformin: a review of its potential indications. Drug Des Devel Ther. 2017 Aug 22;11:2421-2429. doi: 10.2147/DDDT.S141675. eCollection 2017.PMID 30459598Jiang Y, Wang Z, Ma B, Fan L, Yi N, Lu B, Wang Q, Liu R. GLP-1 Improves Adipocyte Insulin Sensitivity Following Induction of Endoplasmic Reticulum Stress. Front Pharmacol. 2018 Oct 16;9:1168. doi: 10.3389/fphar.2018.01168. eCollection 2018.PMID 37653215Liao M, Li X, Zhang H, Zhou L, Shi L, Li W, Shen R, Peng G, Zhao H, Shao J, Wang X, Sun Z, Zheng H, Long M. Effects and plasma proteomic analysis of GLP-1RA versus CPA/EE, in combination with metformin, on overweight PCOS women: a randomized controlled trial. Endocrine. 2024 Jan;83(1):227-241. doi: 10.1007/s12020-023-03487-4. Epub 2023 Aug 31.

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