Absolute and relative contribution of basal and postprandial blood glucose to the overall condition of blood glucose in type 2 diabetic patients treated with oral anti-diabetic drugs.

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OOC-15006440
• Date of registration: 2015-05-23
• Prospective Registration: Yes
• Primary sponsor: West China Hospital of Sichuan University
• Public title: Absolute and relative contribution of basal and postprandial blood glucose to the overall condition of blood glucose in type 2 diabetic patients treated with oral anti-diabetic drugs.
• Scientific title: Absolute and relative contribution of basal and postprandial blood glucose to the overall condition of blood glucose in type 2 diabetic patients treated with oral anti-diabetic drugs.
• Date of first enrolment: 2015-05-31
• Target sample size: the type 2 diabetes group:300;the normal glucose tolerance group:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11032
• Study type: Observational study
• Study design: Cross-sectional
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Xingu Ran

• Name: Xingu Ran
• Affiliation: West China Hospital of Sichuan University

Key inclusion & exclusion criteria

Inclusion criteria: Normal glucose tolerance group:
1) subjects aged 18-75 years;
2) subjects with normal results of blood tests, such as complete blood count and blood chemistries, as well as urinalysis;
3) BMI from 18.5 to 24.9 kg/m2;
4) subjects with normal blood lipid, blood pressure as well as blood glucose and insulin in OGTT;
5) subjects not been prescribed with any drug which might influence the metabolism of blood glucose within 1 month before screening;
6) subjects who have signed the information consent form.
Type 2 diabetes group:
1) subjects aged 18-75 years;
2) subjects with diabetes according to WHO1999: either fasting plasma glucose (FPG) >=7.0 mmol/L or 2h postprandial plasma glucose (2h PG) >=11.1 mmol/L in OGTT;
3) subjects with diabetes duration of more than 6 months;
4) subjects only treated with oral anti-diabetic drugs and the anti-diabetic approach remaining unchanged within 3 months before screening;
5) subjects not been prescribed with any drugs which might influence the metabolism of blood glucose within 1 month before screening;
6) subjects who have signed the information consent form.
Exclusion criteria: 1) subjects treated with anti-postprandial hyperglycemic drugs, such as alpha-glucosidase inhibitors, glinides, DPP4 inhibitors, GLP-1 analogues and insulin, within 3 months before screening;
2) patients with unstable angina pectoris, severe angina pectoris, myocardial infarction or congestive heart failure;
3) patients with severe hepatic or renal dysfunction (AST and ALT > 2 folds of the upper limits of normal range respectively; Creatinine > 1.2 folds of the upper limit of normal range or eGFR <30ml/min);
4) subjects with any potential factors which might result in sharp fluctuations of blood glucose, such as acute infection, injury, surgical operation and malignant tumour;
5) pregnant and lactation women;
6) patients with any fatal diseases;
7) subjects with psychological diseases or poor self-cognition;
8) subjects who have taken part in other clinical trials within 3 months before screening;
9) Other conditions assessed by the investigators not appropriate for participating in this trail.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

type 2 diabetes

Intervention(s)

the type 2 diabetes group:current anti-diabetic treatments;the normal glucose tolerance group:None ;

Primary Outcome(s)

Area Under the Curve (AUC)-basal blood glucose (BBG), AUC-postprandial blood glucose (PBG), AUC-total blood glucose all day (T) in CGMS;HbA1c;

Secondary Outcome(s)

asting and postprandial blood glucose in OGTT;

Source(s) of Monetary Support

Sanofi (Beijing) Pharmaceuticals Co., Ltd