Myocardial Pathological Changes in Patients of Type 2 Diabetes With or Without PCOS Using Cardiac Magnetic Resonance
2021年3月16日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
561
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Shanghai
-
Shanghai、Shanghai、中国、200127
- 募集
- RenJi Hospital Department of Endocrinology and Metabolism
-
コンタクト:
- Tao Tao, MD
- 電話番号:+86-021-68383073
- メール:taotaosh76@163.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年~40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the change level of cardiac extracellular volume (ECV)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in the level of troponin I (TNI)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Tao Tao, Dr.、Renji Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年2月20日
一次修了 (予想される)
2022年2月1日
研究の完了 (予想される)
2022年2月1日
試験登録日
最初に提出
2021年3月2日
QC基準を満たした最初の提出物
2021年3月16日
最初の投稿 (実際)
2021年3月18日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月18日
QC基準を満たした最後の更新が送信されました
2021年3月16日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。