ClinicalTrials.gov
ClinicalTrials.gov Menu

The Study to Investigate the Contribution of Basal and Postprandial Glucose to Overall Hyperglycemia in T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02648685
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Xingwu Ran, West China Hospital

Brief Summary:
There was no any China mainland data showing the contribution of BBG and PBG to HbA1c in T2DM patients treated with OADs using the CGM method. Therefore this study is aimed to investigate the contribution of BBG and PBG to HbA1c in Chinese T2DM patients treated with OADs using CGMS. It's expected to generate evidence to support the concept of individualized therapy when patients are uncontrolled by OADs.

Condition or disease
Diabetes, Type 2

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Study to Investigate the Contribution of Basal and Post-prandial Blood Glucose to Overall Glycaemia in Subjects With Normal Glycaemic Metabolism and Type 2 Diabetes
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Group/Cohort
normal glycaemic metabolism
100 subjects
Type 2 Diabetes
300 subjects



Primary Outcome Measures :
  1. the proportion of basal/post-prandial blood glucose contributed to the overall glycaemia(HbA1c) [ Time Frame: 72 hours ]

    Glycaemia level is measured by Area under the curve(AUC).The curve is based on the glycaemia value measured by the continuous glucose monitoring system (CGMS). for example:Total high glycaemia= AUC (24h total high glycaemia)=the area above the curve of FBG 6.1 mmol/L,AUC(post-prandial blood glucose,PPG )=(the area above pre-prandial glucose in a 4-h period after each meal)x3 meals,AUC(basal blood glucose,BBG)= AUC(24h total high glycaemia) - AUC(PPG).

    Relative contribution of BBG= AUC(BBG)/ AUC(24h total high glycaemia)X100% Relative contribution of PPG= AUC(PPG)/ AUC(24h total high glycaemia)X100%




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Age 18-75 years old, male or female
  • Normal glycaemic and normal weight subjects:

    • Normal results of routine blood and urine tests
    • Normal kidney and liver function
    • BMI >=18.5 and <=24.9 Kg/m2
    • Normal blood lipid profile
    • Normal blood pressure
    • Normal OGTT (according WHO 1999 criteria)
  • T2DM subjects:

    • Diagnosed according WHO 1999 criteria
    • Duration of T2DM diabetes>=6 months
    • Treated with stable regimen of OADs >=3 months
  • The subjects didn't receive any drug with potential impact on glycemic metabolism in the last one month
  • Will sign the consent form
Criteria

Inclusion Criteria:

  • Age 18-75 years old, male or female
  • Normal glycaemic and normal weight subjects:

    • Normal results of routine blood and urine tests
    • Normal kidney and liver function
    • BMI >=18.5 and <=24.9 Kg/m2
    • Normal blood lipid profile
    • Normal blood pressure
    • Normal OGTT (according WHO 1999 criteria)
  • T2DM subjects:

    • Diagnosed according WHO 1999 criteria
    • Duration of T2DM diabetes>=6 months
    • Treated with stable regimen of OADs >=3 months
  • The subjects didn't receive any drug with potential impact on glycemic metabolism in the last one month
  • Will sign the consent form

Exclusion Criteria:

  • Have any sever cardiac disease including unstable angina, sever angina, cardiac infarction, or congestive heart failure
  • Have obvious liver or kidney disease (e.g. alanine aminotransferase and aspartate aminotransferase increased 2 times than the normal upper limit respectively, serum creatinine increased 1.2 times than the normal upper limit)
  • Have any serious disease which is life threatening
  • Pregnancy or breast-feeding women
  • Have any mental disorders, lack self-control, or be not able to express accurately
  • Participate other studies in the last 3 months
  • Ever received AGI, Glinides, DPP-IV inhibitors, GLP-1 analogues or insulin in the past 3 months
  • Other patients who is not suitable to participate this study at the discretion of physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648685


Locations
China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610042
Sponsors and Collaborators
West China Hospital
Investigators
Principal Investigator: Xingwu Ran, Doctor West China Hospital. Endocrinology Department.

Additional Information:
Publications of Results:

Responsible Party: Xingwu Ran, Clinical Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT02648685     History of Changes
Other Study ID Numbers: Sanofi-023
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Keywords provided by Xingwu Ran, West China Hospital:
post prandial glucose (PPG)
basal blood glucose (BBG)
overall glycaemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases