Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)
2015년 8월 19일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
70
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guangdong
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Guangzhou City, Guangdong, 중국, 510630
- 모병
- Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
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연락하다:
- Zeng Longyi, Professor
- 전화번호: 0086-020-85252160
- 이메일: zssynfmk@163.com
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연락하다:
- Lin Shuo, Doctor
- 전화번호: 0086-020-85253408
- 이메일: littltpig@yeah.net
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수석 연구원:
- Zeng Longyi, Professor
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부수사관:
- lin Shuo, Doctor
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
25년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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
다른 이름들:
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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mean amplitude of glycemic excursions( MAGE)
기간: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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glycated hemoglobin A1c
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
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From date of randomization until the end of study, assessed up to 15 days
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insulin secretion-sensitivity index
기간: From date of randomization until the end of study, assessed up to 15 days
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changes of insulin secretion-sensitivity 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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disposition index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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the incidence of hypoglycemia
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 7월 1일
기본 완료 (예상)
2016년 8월 1일
연구 완료 (예상)
2016년 9월 1일
연구 등록 날짜
최초 제출
2015년 8월 10일
QC 기준을 충족하는 최초 제출
2015년 8월 15일
처음 게시됨 (추정)
2015년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 8월 19일
마지막으로 확인됨
2015년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20130319c
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
제2형 당뇨병에 대한 임상 시험
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Postgraduate Institute of Medical Education and...완전한
insulin lispro에 대한 임상 시험
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