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

16 marzo 2021 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

561

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Shanghai
      • Shanghai, Shanghai, Cina, 200127
        • Reclutamento
        • Renji Hospital Department of Endocrinology and Metabolism
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 40 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
the change level of cardiac extracellular volume (ECV)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
change in the level of troponin I (TNI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Tao Tao, Dr., Renji hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 febbraio 2020

Completamento primario (Anticipato)

1 febbraio 2022

Completamento dello studio (Anticipato)

1 febbraio 2022

Date di iscrizione allo studio

Primo inviato

2 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2021

Primo Inserito (Effettivo)

18 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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