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Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)

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ClinicalTrials.gov Identifier: NCT02526810
Recruitment Status : Unknown
Verified August 2015 by Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : August 18, 2015
Last Update Posted : August 20, 2015
Sponsor:
Collaborator:
Guangdong Provincial Department of Science and Technology
Information provided by (Responsible Party):
Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: insulin lispro Drug: Insulin Glargine Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
Study Start Date : July 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
Drug: insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Other Name: Humalog

Experimental: 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.
Drug: Insulin Glargine
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Other Name: Lantus




Primary Outcome Measures :
  1. mean amplitude of glycemic excursions( MAGE) [ Time Frame: 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.


Secondary Outcome Measures :
  1. glycated hemoglobin A1c [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of HbA1c before and after the intervention

  2. glycated albumin [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of glycated albumin before and after the intervention

  3. fasting plasma glucose, postprandial plasma glucose (30min, 120min) [ Time Frame: 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

  4. Fasting C-peptide [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of Fasting C-peptide before and after the intervention

  5. Fasting insulin [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of Fasting insulin before and after the intervention

  6. Homa-β [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of Homa-β before and after the intervention

  7. insulin secretion-sensitivity index [ Time Frame: 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

  8. disposition index [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of disposition index before and after the intervention

  9. standard deviation of glucose level [ Time Frame: during three days' CGMS ]
    standard deviation of glucose level

  10. area under curve (AUC) when the glucose level was higher than 7.8mmol/L [ Time Frame: during three days' CGMS ]
    AUC when the glucose level was higher than 7.8mmol/L

  11. area under curve (AUC) when the glucose level was lower than 3.9mmol/L [ Time Frame: during three days' CGMS ]
    AUC when the glucose level was higher than 3.9mmol/L

  12. thiobarbituric acid reactive substance [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    changes of thiobarbituric acid reactive substance before and after the intervention

  13. the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG) [ Time Frame: 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


Other Outcome Measures:
  1. the incidence of hypoglycemia [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L

  2. the incidence of severe hypoglycemia [ Time Frame: From date of randomization until the end of study, assessed up to 15 days ]
    defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
  2. 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
  3. Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
  4. agree to participate the study and sign the informed consent.

Exclusion Criteria:

  1. obvious failure of heart, hepatic, kidney function.
  2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
  3. women in pregnancy or planning to get pregnancy.

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): NCT02526810


Contacts
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Contact: Zeng Longyi, professor 0086-020-85252160 zssynfmk@163.com
Contact: Lin Shuo, doctor 0086-020-85253408 littltpig@yeah.net

Locations
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China, Guangdong
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University Recruiting
Guangzhou City, Guangdong, China, 510630
Contact: Zeng Longyi, Professor    0086-020-85252160    zssynfmk@163.com   
Contact: Lin Shuo, Doctor    0086-020-85253408    littltpig@yeah.net   
Principal Investigator: Zeng Longyi, Professor         
Sub-Investigator: lin Shuo, Doctor         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial Department of Science and Technology
Investigators
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Principal Investigator: Zeng Longyi, professor Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Publications:

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Responsible Party: Longyi Zeng, Head of Endocrinology and Metabolism department, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02526810    
Other Study ID Numbers: 20130319c
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University:
glargine
continuous subcutaneous insulin injection
blood glucose control
blood glucose fluctuation
Oxidative Stress
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs