Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)
2015年8月19日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
70
段階
- フェーズ 4
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
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Guangdong
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Guangzhou City、Guangdong、中国、510630
- 募集
- Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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コンタクト：
- Zeng Longyi, Professor
- 電話番号：0086-020-85252160
- メール：zssynfmk@163.com
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コンタクト：
- Lin Shuo, Doctor
- 電話番号：0086-020-85253408
- メール：littltpig@yeah.net
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主任研究者：
- Zeng Longyi, Professor
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副調査官：
- lin Shuo, Doctor
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-
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
25年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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
他の名前：
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実験的：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
他の名前：
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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 |
|---|---|---|
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mean amplitude of glycemic excursions( MAGE)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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glycated hemoglobin A1c
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
|
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fasting plasma glucose, postprandial plasma glucose (30min, 120min)
時間枠：From date of randomization until the end of study, assessed up to 15 days
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changes of fasting and postprandial plasma glucose 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 C-peptide
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
|
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Homa-β
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
時間枠：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
|
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disposition index
時間枠：From date of randomization until the end of study, assessed up to 15 days
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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
時間枠：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
時間枠：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
時間枠：during three days' CGMS
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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
時間枠：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)
時間枠：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
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From date of randomization until the end of study, assessed up to 15 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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the incidence of hypoglycemia
時間枠：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
時間枠：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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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。
捜査官
- 主任研究者：Zeng Longyi, professor、Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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
- 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.
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
2015年7月1日
一次修了 (予想される)
2016年8月1日
研究の完了 (予想される)
2016年9月1日
試験登録日
最初に提出
2015年8月10日
QC基準を満たした最初の提出物
2015年8月15日
最初の投稿 (見積もり)
2015年8月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年8月20日
QC基準を満たした最後の更新が送信されました
2015年8月19日
最終確認日
2015年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20130319c
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