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Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance

16 mars 2021 mis à jour par: RenJi Hospital
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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

561

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Shanghai
      • Shanghai, Shanghai, Chine, 200127
        • Recrutement
        • RenJi Hospital Department of Endocrinology and Metabolism
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 40 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

Inclusion Criteria:

  1. Age 30-40 years old;
  2. Overweight and obese women with/without type 2 diabetes without PCOS, PCOS without type 2 diabetes, and type 2 diabetes with PCOS;
  3. HbA1C 7-9% of patients with type 2 diabetes;
  4. Increased risk of cardiovascular disease (with any one of the following risk factors: hypertension, dyslipidemia, hyperuricemia, obesity, smoking);
  5. 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;
  6. Willing to participate in this study and sign an informed consent form.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. Symptomatic heart failure in the past 6 months, or left ventricular ejection fraction <35%;
  4. 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) ;
  5. Pregnancy;
  6. Participated in clinical trials of other drugs within 3 months;
  7. 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;
  8. A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
  9. The subject is allergic to the contrast agent (gadopentetate meglumine injection);
  10. The subject has claustrophobia;
  11. The subject contains metal implants that are not suitable for cardiac magnetic resonance examination;
  12. Any conditions judged by the investigator that affect enrollment.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
the change level of cardiac extracellular volume (ECV)
Délai: 3 years
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
change in the level of troponin I (TNI)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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)
Délai: 3 years
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Tao Tao, Dr., Renji Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 février 2020

Achèvement primaire (Anticipé)

1 février 2022

Achèvement de l'étude (Anticipé)

1 février 2022

Dates d'inscription aux études

Première soumission

2 mars 2021

Première soumission répondant aux critères de contrôle qualité

16 mars 2021

Première publication (Réel)

18 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mars 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

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