- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02774733
Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters (PSV, EDV, RI) of Retrobulbar Blood Vessels (CRA, PCA, and OA) in 48 T2DM Patients Did Not Combinate With DR (CPCT2DM)
Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters of Retrobulbar Blood Vessels in Patients With Type 2 Diabetes
Objective: The main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (T2DM) without diabetic retinopathy (DR).
Method: T2DM patients without DR were choose to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c, FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler imaging (CDI).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the retrobulbar circulation (PSV, EDV, RI);retrobulbar blood vessels (CRA, PCA, and OA);blood-fat(TC, HDL-C, LDL-C, and TG).
Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; The CDI recordings were taken using a Powervision SSA-380A (Toshiba, Japan) using a 7-MHz transducer.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association;
- No smoking history, pulmonary disease nor pulmonary infection within a fortnight;
- Did not have hepatopathy, nephropathy, and gastrointestinal disease; and
- Likely to have good compliance and able to visit our hospital for periodic assessments.
Exclusion Criteria:
- T1DM, gestation and lactation;
- Renal inadequacy, a serum creatinine >132 µmol/L (male), or a serum creatinine >123 µmol/L (female);
- hypohepatia, the liver enzyme was two times higher than normal;
- Intensive care with insulin treatment;
- The patients combinated with DR and hypertension (antihypertensive drugs were used);
- Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or introacular surgery;
- New York Heart Association class III or IV heart failure, a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months; 8) Cholesterol-lowering drugs can not control the blood-fat (TC > 250 mg/dl, HDL-C < 30 mg/dL, LDL-C > 170 mg/dl, TG > 200 mg/dl) adequately; and
9) Use of systemically injected glucocorticoids within 3 months prior to our study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared
Lasso di tempo: one week
|
pulmonary function parameters include: VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%;HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
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one week
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The circulatory parameters (using CDI)of retrobulbar blood vessels of three categories of patients, based on HbA1c levels, were compared
Lasso di tempo: one week
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retrobulbar blood vessels include CRA, PCA, and OA; circulatory parameters include PSV, EDV, and RI; HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
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one week
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The correlation between the pulmonary function parameters and the retrobulbar circulation parameters in 48 T2DM patients
Lasso di tempo: one week
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one week
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients
Lasso di tempo: one week
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blood-fat include TC, HDL-C, LDL-C, and TG
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one week
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Altri numeri di identificazione dello studio
- F11-262-9-25 (Natural Science Foundation of Shenyang)
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 .
Prove cliniche su spirometer;Intraocular pressure;Color doppler imaging
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