Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)
19 augustus 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Verwacht)
70
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Guangdong
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Guangzhou City, Guangdong, China, 510630
- Werving
- Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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Contact:
- Zeng Longyi, Professor
- Telefoonnummer: 0086-020-85252160
- E-mail: zssynfmk@163.com
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Contact:
- Lin Shuo, Doctor
- Telefoonnummer: 0086-020-85253408
- E-mail: littltpig@yeah.net
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Hoofdonderzoeker:
- Zeng Longyi, Professor
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Onderonderzoeker:
- lin Shuo, Doctor
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
25 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8
IU/kg.
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continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Andere namen:
|
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Experimenteel: 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.
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long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
mean amplitude of glycemic excursions( MAGE)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
glycated hemoglobin A1c
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
|
changes of HbA1c before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
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glycated albumin
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
|
changes of Fasting C-peptide before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
|
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Fasting insulin
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
|
changes of Fasting insulin before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
|
|
Homa-β
Tijdsspanne: 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
|
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insulin secretion-sensitivity index
Tijdsspanne: 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
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
|
changes of disposition index before and after the intervention
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From date of randomization until the end of study, assessed up to 15 days
|
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standard deviation of glucose level
Tijdsspanne: 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
Tijdsspanne: during three days' CGMS
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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
Tijdsspanne: during three days' CGMS
|
AUC when the glucose level was higher than 3.9mmol/L
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during three days' CGMS
|
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thiobarbituric acid reactive substance
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
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changes of thiobarbituric acid reactive substance before and after the intervention
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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)
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
|
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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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the incidence of hypoglycemia
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
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the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L
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From date of randomization until the end of study, assessed up to 15 days
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the incidence of severe hypoglycemia
Tijdsspanne: From date of randomization until the end of study, assessed up to 15 days
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defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L
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From date of randomization until the end of study, assessed up to 15 days
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2015
Primaire voltooiing (Verwacht)
1 augustus 2016
Studie voltooiing (Verwacht)
1 september 2016
Studieregistratiedata
Eerst ingediend
10 augustus 2015
Eerst ingediend dat voldeed aan de QC-criteria
15 augustus 2015
Eerst geplaatst (Schatting)
18 augustus 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
20 augustus 2015
Laatste update ingediend die voldeed aan QC-criteria
19 augustus 2015
Laatst geverifieerd
1 augustus 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20130319c
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