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The study is prepared to use CMR technology for early screening of myocardial lesions in 561 age-matched women with type 2 diabetes without PCOS, with PCOS without type 2 diabetes and with type 2 diabetes combined with PCOS, compare the differences between the two groups of cardiomyocyte injury changes, and treat and follow-up with type 2 diabetes and PCOS in accordance with the current standard treatment guidelines for type 2 diabetes and PCOS, after 3 years of follow-up we will analyse the changes in cardiomyopathy, cardiac serological indicators, and heart function indicators,which can provide theoretical basis for early clinical intervention in the future.
So far, due to the lack of more sensitive noninvasive detection methods and indicators that suggest early cardiomyopathy, it is not clear whether type 2 diabetes combined with PCOS will lead to earlier and more progressive changes in cardiomyopathy, and whether there is a difference with type 2 diabetes alone and early cardiomyopathy in patients with simple PCOS.Compared with women with type 2 diabetes who did not combine polycystic Ovary Syndrome(PCOS) or PCOS did not combine with type 2 diabetes, patients with type 2 diabetes who combined PCOS had the characteristics of lower age of onset, longer exposure to high risk factors of CVD, and higher risk of cardiovascular disease on the basis of the dual pathophysiology of insulin resistance and hyperandrogenism.The purpose of this study is to find early cardiovascular disease of women with type 2 diabetes and PCOS and conduct early clinical intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 2 diabetes without polycystic ovary syndrome | The treatment of type 2 diabetes is based on the Chinese Medical Association Diabetes Branch '2017 China Type 2 Diabetes Prevention Guidelines' for lifestyle adjustment and diabetes drug treatment.The research physician decides the diabetes treatment measures of the research object; the blood sugar control goal is that glycosylated hemoglobin is less than 7%. | ||
| polycystic ovary syndrome without type 2 diabetes | The treatment of polycystic ovary syndrome is based on the '2018 Polycystic Ovary Syndrome Chinese Diagnosis and Treatment Guidelines' by the Endocrinology Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association and the Guide Expert Group '2018 Polycystic Ovary Syndrome Expert consensus on diagnosis and treatment of endocrinology' for lifestyle and drug treatment. | ||
| polycystic ovary syndrome with type 2 diabetes | Treatment is as above. |
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| Measure | Description | Time Frame |
|---|---|---|
| the change level of cardiac extracellular volume (ECV) | Compared with baseline, the change level of cardiac extracellular volume (ECV) in patients with type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| change in the level of troponin I (TNI) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of TNI in ng/ml. | 3 years |
| change in the level of creatine kinase isoenzymes (CK-MB) |
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Inclusion Criteria:
Exclusion Criteria:
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Overweight/obese women with type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS were expected enrolled in our study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Tao, Dr. | Contact | 86-021-68383073 | taotaosh76@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Tao, Dr. | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Department of Endocrinology and Metabolism | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21263450 | Background | Goodarzi MO, Dumesic DA, Chazenbalk G, Azziz R. Polycystic ovary syndrome: etiology, pathogenesis and diagnosis. Nat Rev Endocrinol. 2011 Apr;7(4):219-31. doi: 10.1038/nrendo.2010.217. Epub 2011 Jan 25. | |
| 14711538 | Background | Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004. |
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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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Whole blood,fasting serum
Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of CK-MB in IU/L. |
| 3 years |
| change in the level of Brain Natriuretic Peptide (BNP) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of BNP in pg/ml. | 3 years |
| change in the level of atrialnatriureticpeptide (ANP) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the serum index related to myocardial injury such as change of ANP in pg/ml. | 3 years |
| change in the level of left ventricular ejection fraction (LVEF) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular ejection fraction (LVEF) in %. | 3 years |
| change in the level of left ventricular end diastolic pressure (LVEDP) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular end diastolic pressure (LVEDP) in kPa/mmHg. | 3 years |
| change in the level of output per minute (CO) in L/min | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: output per minute (CO) in L/min. | 3 years |
| change in the level of left ventricular diameter reduction rate (FS) | Compared with the baseline in three groups and T2DM with different phenotype of PCOS, the cardiac functions change such as: left ventricular diameter reduction rate (FS) in %. | 3 years |
| Changes in score of Minnesota heart failure quality of life scale(LiHFe) | Compared with the baseline in three groups, the changes of Minnesota heart failure quality of life scale(LiHFe) in score, higher scores mean a worse outcome. (Scores ranging from 0 to 105) | 3 years |
| Changes in score of short form 12 questionnaire(SF-12) | Compared with the baseline in three groups, the changes of SF-12 in score, higher scores mean a better outcome. (Scores ranging from 0 to 65) | 3 years |
| Changes in score of Generalized Anxiety Disorder-7(GAD-7) | Compared with the baseline in three groups, the changes of GAD-7 in score, higher scores mean a worse outcome. (Scores ranging from 0 to 21) | 3 years |
| Changes in score of Patient Health Questionnaire-9(PHQ-9) | Compared with the baseline in three groups, the changes of PHQ-9 in score, higher scores mean a worse outcome. (Scores ranging from 0 to 27) | 3 years |
| 19805654 | Background | Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. |
| 26488852 | Background | Mahalingaiah S, Diamanti-Kandarakis E. Targets to treat metabolic syndrome in polycystic ovary syndrome. Expert Opin Ther Targets. 2015;19(11):1561-74. doi: 10.1517/14728222.2015.1101067. Epub 2015 Oct 21. |
| 22767467 | Background | Lim SS, Davies MJ, Norman RJ, Moran LJ. Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):618-37. doi: 10.1093/humupd/dms030. Epub 2012 Jul 4. |
| 23940991 | Background | Baldani DP, Skrgatic L, Goldstajn MS, Vrcic H, Canic T, Strelec M. Clinical, hormonal and metabolic characteristics of polycystic ovary syndrome among obese and nonobese women in the Croatian population. Coll Antropol. 2013 Jun;37(2):465-70. |
| 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 |