Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Anticipado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Tao Tao, Dr.
- Número de teléfono: 86-021-68383073
- Correo electrónico: taotaosh76@163.com
Ubicaciones de estudio
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Shanghai
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Shanghai, Shanghai, Porcelana, 200127
- Reclutamiento
- RenJi Hospital Department of Endocrinology and Metabolism
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Contacto:
- Tao Tao, MD
- Número de teléfono: +86-021-68383073
- Correo electrónico: taotaosh76@163.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 30-40 years old;
- Overweight and obese women with/without type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS;
- HbA1C 7-9% of patients with type 2 diabetes;
- Increased risk of cardiovascular disease (with any one of the following risk factors: hypertension, dyslipidemia, hyperuricemia, obesity, smoking);
- The diagnosis of PCOS is based on the 2003 Rotterdam criteria, the diagnosis of overweight/obesity is based on the WHO-WPR criteria, and the diagnosis criteria of type 2 diabetes is based on the 1998 WHO diagnosis criteria;
- Willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
- Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
- Congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, atrial fibrillation, viral myocarditis, infectious myocarditis, hyperthyroid heart disease, cardiac amyloidosis and other myocardial damage diseases, NYHA heart function classification ≥ Grade III, or the subject has had a clinical cardiovascular event in the past 3 months;
- Symptomatic heart failure in the past 6 months, or left ventricular ejection fraction <35%;
- Self-reported or medical records are type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as diabetes caused by Cushing syndrome, abnormal thyroid function, or acromegaly) ;
- Pregnancy;
- Participated in clinical trials of other drugs within 3 months;
- In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
- A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
- The subject is allergic to the contrast agent (gadopentetate meglumine injection);
- The subject has claustrophobia;
- The subject contains metal implants that are not suitable for cardiac magnetic resonance examination;
- Any conditions judged by the investigator that affect enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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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%.
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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.
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polycystic ovary syndrome with type 2 diabetes
Treatment is as above.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the change level of cardiac extracellular volume (ECV)
Periodo de tiempo: 3 years
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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
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3 years
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in the level of troponin I (TNI)
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of creatine kinase isoenzymes (CK-MB)
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of Brain Natriuretic Peptide (BNP)
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of atrialnatriureticpeptide (ANP)
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of left ventricular ejection fraction (LVEF)
Periodo de tiempo: 3 years
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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 %.
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3 years
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change in the level of left ventricular end diastolic pressure (LVEDP)
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of output per minute (CO) in L/min
Periodo de tiempo: 3 years
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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.
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3 years
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change in the level of left ventricular diameter reduction rate (FS)
Periodo de tiempo: 3 years
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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 %.
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3 years
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Changes in score of Minnesota heart failure quality of life scale(LiHFe)
Periodo de tiempo: 3 years
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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)
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3 years
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Changes in score of short form 12 questionnaire(SF-12)
Periodo de tiempo: 3 years
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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)
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3 years
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Changes in score of Generalized Anxiety Disorder-7(GAD-7)
Periodo de tiempo: 3 years
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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)
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3 years
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Changes in score of Patient Health Questionnaire-9(PHQ-9)
Periodo de tiempo: 3 years
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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)
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3 years
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Tao Tao, Dr., Renji Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Anticipado)
Finalización primaria
Finalización del estudio (Anticipado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- KY2020-198
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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