Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)
19. august 2015 oppdatert av: Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University
The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study was a single-center, randomized, controled and prospective trial.
Type 2 diabetic patients were randomized into 2 groups (Group A and Group B).
Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets).
After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days.
Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours.
The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day.
In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al.
The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.
Studietype
Intervensjonell
Registrering (Forventet)
70
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Guangdong
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Guangzhou City, Guangdong, Kina, 510630
- Rekruttering
- Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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Ta kontakt med:
- Zeng Longyi, Professor
- Telefonnummer: 0086-020-85252160
- E-post: zssynfmk@163.com
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Ta kontakt med:
- Lin Shuo, Doctor
- Telefonnummer: 0086-020-85253408
- E-post: littltpig@yeah.net
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Hovedetterforsker:
- Zeng Longyi, Professor
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Underetterforsker:
- lin Shuo, Doctor
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-
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
25 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
- diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
- Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
- agree to participate the study and sign the informed consent.
Exclusion Criteria:
- obvious failure of heart, hepatic, kidney function.
- severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
- women in pregnancy or planning to get pregnancy.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8
IU/kg.
|
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Andre navn:
|
|
Eksperimentell: GROUP B
using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd.
|
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
mean amplitude of glycemic excursions( MAGE)
Tidsramme: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
|
a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.
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3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
glycated hemoglobin A1c
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of HbA1c before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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glycated albumin
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of glycated albumin before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
|
|
fasting plasma glucose, postprandial plasma glucose (30min, 120min)
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of fasting and postprandial plasma glucose before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
Fasting C-peptide
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of Fasting C-peptide before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
Fasting insulin
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of Fasting insulin before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
Homa-β
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of Homa-β before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
insulin secretion-sensitivity index
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of insulin secretion-sensitivity index before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
disposition index
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of disposition index before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
|
standard deviation of glucose level
Tidsramme: during three days' CGMS
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standard deviation of glucose level
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during three days' CGMS
|
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area under curve (AUC) when the glucose level was higher than 7.8mmol/L
Tidsramme: during three days' CGMS
|
AUC when the glucose level was higher than 7.8mmol/L
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during three days' CGMS
|
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area under curve (AUC) when the glucose level was lower than 3.9mmol/L
Tidsramme: during three days' CGMS
|
AUC when the glucose level was higher than 3.9mmol/L
|
during three days' CGMS
|
|
thiobarbituric acid reactive substance
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
changes of thiobarbituric acid reactive substance before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
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the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
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changes of the level of blood 8-OHdG substance before and after the intervention
|
From date of randomization until the end of study, assessed up to 15 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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the incidence of hypoglycemia
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L
|
From date of randomization until the end of study, assessed up to 15 days
|
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the incidence of severe hypoglycemia
Tidsramme: From date of randomization until the end of study, assessed up to 15 days
|
defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L
|
From date of randomization until the end of study, assessed up to 15 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
- Hanson RL, Pratley RE, Bogardus C, Narayan KM, Roumain JM, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC. Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemiologic studies. Am J Epidemiol. 2000 Jan 15;151(2):190-8. doi: 10.1093/oxfordjournals.aje.a010187.
- Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.
- Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
- Mu PW, Chen YM, Lu HY, Wen XQ, Zhang YH, Xie RY, Shu J, Wang MM, Zeng LY. Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes. Diabetes Metab Res Rev. 2012 Mar;28(3):236-40. doi: 10.1002/dmrr.1292.
- Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-cell function improvement in newly diagnosed type 2 diabetes patients: basal insulin monotherapy versus continuous subcutaneous insulin infusion treatment. Diabetes Technol Ther. 2012 Jan;14(1):35-42. doi: 10.1089/dia.2011.0123. Epub 2011 Aug 30. Erratum In: Diabetes Technol Ther. 2014 Mar;16(3):193.
- Brun E, Zoppini G, Zamboni C, Bonora E, Muggeo M. Glucose instability is associated with a high level of circulating p-selectin. Diabetes Care. 2001 Sep;24(9):1685. doi: 10.2337/diacare.24.9.1685. No abstract available.
- Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. doi: 10.2337/diacare.23.1.45.
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. juli 2015
Primær fullføring (Forventet)
1. august 2016
Studiet fullført (Forventet)
1. september 2016
Datoer for studieregistrering
Først innsendt
10. august 2015
Først innsendt som oppfylte QC-kriteriene
15. august 2015
Først lagt ut (Anslag)
18. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20130319c
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