Primary outcomeMean· 12 weeks
Assessment of Reproductive Functions
| Group | Value (mIU/ml) | Spread |
|---|---|---|
| Metformin-GLP-1 Receptor Agonist | 5.52 | 3.37 |
| Metformin-Oral Contraceptive(OC) | 5.33 | 2.52 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataThe Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
NCTNCT03151005 (opens ClinicalTrials.gov in a new tab)Other idXinqiao Endocrinology
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 70 participants (actual)
- Sponsor
- Xinqiao Hospital of Chongqing · Other
- Design
- Randomized · Triple masking
- Countries
1 country
China
- Start
- 1 Jul 2017
- Primary completion
- 1 Apr 2021
- Completion
- 23 Apr 2021
- First posted
- 12 May 2017
- Last update posted
- 4 Dec 2023
- Conditions
- Polycystic Ovary Syndrome (PCOS) · Overweight · Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019202020212022
- Ph 4
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS
NCT031510051 Jul 2017 to 23 Apr 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Metformin-GLP-1 Receptor AgonistDrug
- Metformin-Oral Contraceptive(OC)Drug
Arms2
Experimental
Metformin-GLP-1 Receptor Agonist
Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.
Active comparator
Metformin-Oral Contraceptive(OC)
Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Assessment of Reproductive Functions
Time frame · 12 weeks
Registry description
Concentration of LH was measured in mIU/ml.
Secondary outcomes(4)
Basic Vital Signs
Time frame · 12 weeks
Registry description
Weight and height will be combined to report BMI in kg/m\^2.
Assessment of Liver Function
Time frame · 12 weeks
Registry description
Alanine transaminase was measured in IU/L.
Assessment of Blood Pressure
Time frame · 12 weeks
Registry description
Systolic blood pressure was measured in mmHg.
Assessment of Reproductive Function
Time frame · 12 weeks
Registry description
Changes in testosterone levels were measured
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· 12 weeks
Basic Vital Signs
| Group | Value (kg/m^2) | Spread |
|---|---|---|
| Metformin-GLP-1 Receptor Agonist | 26.26 | 3.67 |
| Metformin-Oral Contraceptive(OC) | 27.12 | 4.04 |
Secondary outcomeMean· 12 weeks
Assessment of Liver Function
| Group | Value (IU/L) | Spread |
|---|---|---|
| Metformin-GLP-1 Receptor Agonist | 39.09 | 24.16 |
| Metformin-Oral Contraceptive(OC) | 36.73 | 43.12 |
Secondary outcomeMean· 12 weeks
Assessment of Blood Pressure
| Group | Value (mmHg) | Spread |
|---|---|---|
| Metformin-GLP-1 Receptor Agonist | 122.83 | 10.91 |
| Metformin-Oral Contraceptive(OC) | 122.40 | 6.39 |
Secondary outcomeMean· 12 weeks
Assessment of Reproductive Function
| Group | Value (nmol/L) | Spread |
|---|---|---|
| Metformin-GLP-1 Receptor Agonist | 1.82 | 0.51 |
| Metformin-Oral Contraceptive(OC) | 2.14 | 1.02 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Metformin-GLP-1 Receptor AgonistMetformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks. Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection. | 0 / 30 | 0 / 30 | 0 / 30 |
| Metformin-Oral Contraceptive(OC)Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks. Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake. | 0 / 30 | 0 / 30 | 1 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2024
16 results
Effects and plasma proteomic analysis of GLP-1RA versus CPA/EE, in combination with metformin, on overweight PCOS women: a randomized controlled trial.
Liao et al. 2024Endocrinecited by 21
PMID 37653215PMC10806039DOI 10.1007/s12020-023-03487-4PUB-37653215
CC BY16 results
More studies
1 study on this page
PubMed tag: none · 2018
GLP-1 Improves Adipocyte Insulin Sensitivity Following Induction of Endoplasmic Reticulum Stress.
Jiang et al. 2018Frontiers in pharmacologycited by 75
PMID 30459598PMC6232689DOI 10.3389/fphar.2018.01168PUB-30459598
CC BY
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultMacut 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 28646699
- ResultZhou 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 12046553
- ResultBarthelmess 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 24389146
- ResultDumesic 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 26426951
- ResultRotterdam 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 14688154
- ResultYildiz 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 22777527
- ResultFarrell 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 20471009
- ResultEscobar-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 29569621
- ResultRuan 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 28463030
- ResultWang 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 28860713
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
PepBank is a research reference. Talk to a doctor before you use any peptide.