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The Effects of Glucocorticoids on Glucose Metabolism in Patients With Interstitial Lung Disease

7. juli 2016 oppdatert av: Peking Union Medical College Hospital

Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease

This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in patients with interstitial lung disease. Patients with interstitial lung disease who is on the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose monitoring (CGM). The data attained from the CGM are used to define the glycemic characteristics in patients using glucocorticoids and the difference of glucose features due to different doses.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

Patients diagnosed of interstitial lung disease and treating with glucocorticoids could be enrolled in this clinical trial. Those who is in an acute inflammatory phase and diagnosed with hemorrhagic disease should are excluded, so are those unwilling to carry the continuous glucose monitoring (CGM) device. When the dose of prednisolone is applied 15mg per day steadily and is going to be decreased, the CGM is conducted. At the same time, blood tests evaluating the glucose metabolism are measured, including HbA1c, GA, fasting insulin and fasting glucose. After taking 7.5mg prednisolone per day for 3 months, participants do the CGM and blood tests again to evaluate the glucose metabolism during this period. The CGM data could be used for the glucose evaluation, which can manifest the glucose characteristics in the circumstances of glucocorticoid use. By comparing the CGM data and the blood tests, the investigators hope to find the different features of the glucose metabolism due to different doses.

Studietype

Observasjonsmessig

Registrering (Forventet)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100730
        • Rekruttering
        • Peking Union Medical College Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Interstitial lung diseases(ILD), also known as diffuse parenchymal lung diseases, are a group of lung diseases with similar clinical, radiological and pathological manifestation. The causes include connective tissue disease-associated interstitial lung diseases, idiopathic interstitial pneumonias, granulomatous lung disorders etc. Most patients with ILD are recommended to take the glucocorticoid treatment. The adverse effects of glucocorticoids include the glucose metabolism disorder, weight gain, high blood pressure and osteoporosis.

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with interstitial lung disease

Exclusion Criteria:

  • Patients who are in an acute inflammatory phase
  • Patients who are diagnosed hemorrhagic disease
  • Patients who are unwilling to carry the continuous glucose monitoring device

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
known diabetes
Participants have been diagnosed diabetes.
known prediabetes
Participants have been diagnosed impaired glucose tolerance or impaired fasting glucose before.
normal glucose tolerance
Participants have done the oral glucose tolerance test and been confirmed the normal glucose tolerance.
unclear glucose tolerance condition
Participants who have not done oral glucose tolerance test or been diagnosed diabetes before.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The interstitial glucose values measured by CGMS (continuous glucose measure service)
Tidsramme: 3 months
A group of interstitial glucose values will be attained by the CGMS, the number of which count up to more than 1000. These data will undergo statistical process. CGM will be conducted twice when the participants take 15mg prednisolone stably and take 7.5mg prednisolone for 3 months. The difference between the two group of data will be evaluated and discussed.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
fasting insulin
Tidsramme: 3 months
The fasting insulin can evaluate the function of pancreatic beta cell to some extent. The fasting insulin will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.
3 months
fasting glucose
Tidsramme: 3 months
The fasting glucose could evaluate the glucose metabolism to some extent. The fasting glucose will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.
3 months
fasting C peptide
Tidsramme: 3 months
The fasting C peptide could evaluate the function of pancreatic beta cell to some extent. The fasting C peptide will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.
3 months
HbA1c
Tidsramme: 3 months
HbA1c could reflect the average blood glucose for 3 months. The HbA1c will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.
3 months
Glycated albumin
Tidsramme: 3 months
The glycated albumin could evaluate the average blood glucose in the previous 2 weeks to 1 month. The glycated albumin will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.
3 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight
Tidsramme: 3 months
The weight of each participant will be recorded to evaluate the weight change during the study.
3 months
waistline
Tidsramme: 3 months
The waistline of each participant will be recorded to evaluate the weight change during the study.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking Union Medical College Hospital

Etterforskere

  • Hovedetterforsker: Weigang Zhao, MD, Endocrinology department, Peking Union Medical College Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2016

Primær fullføring (Forventet)

1. mars 2017

Studiet fullført (Forventet)

1. mars 2017

Datoer for studieregistrering

Først innsendt

15. mai 2016

Først innsendt som oppfylte QC-kriteriene

2. juli 2016

Først lagt ut (Anslag)

7. juli 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Zhao-ZS965

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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