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出境医 / 临床实验 / Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction

Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction

Study Description
Brief Summary:
The present randomized control trial sought to establish glucose fluctuation as an important target for management on metabolic index, neurologic function, and quality of life in Type 2 diabetes mellitus (T2DM) patients and cerebral infarction (CI).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes and Cerebral Infarction Behavioral: Control group Behavioral: Glucose fluctuation targeted intervention Not Applicable

Detailed Description:
There is a significant association between glycemic fluctuation and the incidence of diabetes macrovascular complications. Therefore, understanding the impact of glycemic fluctuations on diabetic macroangiopathy could be helpful for discovering a strategy of prevention and treatment of macroangiopathy in diabetes. However, previous studies on the glycemic fluctuation in T2DM patients with CI were cross-sectional studies, there has been no prospective intervention study confirming the effects of glucose fluctuation targeted management on the prognosis of T2DM patients following CI. Based on previous fingdings, investigators will assess the effects of glucose fluctuation targeted intervention on metabolic index, neurologic function, and quality of life in T2DM patients and CI.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : June 18, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Control group

During hospitalization:

  1. Monitor subjects' blood glucose;
  2. One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations;
  3. Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose.

During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge.

Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month.

Behavioral: Control group

During hospitalization:

  1. Monitor subjects' blood glucose;
  2. One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations;
  3. Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose.

During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge.

Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month.


Experimental: Glucose fluctuation targeted intervention
We set achieving goals for this intervention group (both A1c<7% and LAGE<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.
Behavioral: Glucose fluctuation targeted intervention
We set achieving goals for this intervention group (both A1c<7% and LAGE<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.

Outcome Measures
Primary Outcome Measures :
  1. Stroke severity [ Time Frame: 6 months ]
    The National Institute of Health Stroke Scale includes the following domains: level of consciousness, sensory, neglect, visual field, gaze, facial palsy, motor arm, motor leg, limb ataxia, language, and dysarthria. Each domain is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).

  2. Glycemic variability [ Time Frame: 6 months ]
    fasting plasma glucose variation coefficient (CV-FPG)

  3. Glucose fluctuation [ Time Frame: 6 months ]
    Largest amplitude of Glycemic Excursions (LAGE)


Secondary Outcome Measures :
  1. Disability and health-related quality of life after stroke [ Time Frame: 6 months ]
    The Stroke Impact Scale (SIS) is a specific scale that evaluates disability and health-related quality of life after stroke. This scale includes the following eight domains: strength, memory, thinking, emotion, communication and ADLs, mobility, hand function and participation. A total of 8 domains with 59 items, are scored on a 5-point scale, of which the sixth, eighth, and ninth questions of the emotional dimension are reversed, and the other items are positive. Each domain scores range from 0 to 100 and are calculated using the following equation: Calculated score=[(actual score- the lowest possible score in this domain) / (the difference between the highest possible score and the lowest score in this domain)]×100. The total score of the scale is the sum of all domains. A higher score indicates better quality of life and the less functional damage.

  2. Independent living skills [ Time Frame: 6 months ]
    The Modified Rankin Scale can discriminate clinically relevant levels of disability and recovery in clinical trials. The 0-6 Likert scale is as follows: 0-no symptoms; 1-no significant disability; 2-slight disability; 3-moderate disability; 4-moderately severe disability; 5-severe disability; and 6-dead. The higher the score, the worse the patient's prognosis. When evaluating prognosis, a score≦2 was classified as a "good".

  3. Glycemic control [ Time Frame: 6 months ]
    Fasting plasma glucose (FPG), 2 hours postprandial blood glucose (2hPG), hemoglobin A1c (HbA1c) will be measured at 6 months.

  4. Blood lipids [ Time Frame: 6 months ]
    High-density lipoprotein-cholesterol (HDL-c), low-density lipoprotein-cholesterol (LDL-c), total cholesterol (TC), triglycerides (TG) will be measured at 6 months.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. cerebral infarction within one month, diagnosed by magnetic resonance imaging (MRI) or computed tomography (CT) according to 1995 acute cerebral infarction diagnosis standards promulgated by the Fourth National Cerebrovascular Disease Conference [1];
  • 2. having type 2 diabetes mellitus (as defined by the WHO diagnostic criteria in 1999) [2];

Exclusion Criteria:

  • 1. coexisting acute complications of diabetes including diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), metabolic acidosis;
  • 2. severe comorbid chronic complications of diabetes;
  • 3. active malignancy;
  • 4. subjects with mental illness and communication disorders; 5) those actively participating in other research studies.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Qingqing Lou, director 8615312019129 lqq188@yahoo.com
Contact: Juan Yan 8613585208910 1678451162@qq.com

Locations
Layout table for location information
China, Jiangsu
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine Recruiting
Nanjing, Jiangsu, China, 210028
Contact: Shujie Hao    8613852293808    1195286284@qq.com   
Contact: Juan Yan    8613585208910    1678451162@qq.com   
Sponsors and Collaborators
Nanjing University of Traditional Chinese Medicine
Investigators
Layout table for investigator information
Principal Investigator: Qingqing Lou, director Nanjing University of Traditional Chinese Medicine
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Stroke severity [ Time Frame: 6 months ]
    The National Institute of Health Stroke Scale includes the following domains: level of consciousness, sensory, neglect, visual field, gaze, facial palsy, motor arm, motor leg, limb ataxia, language, and dysarthria. Each domain is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
  • Glycemic variability [ Time Frame: 6 months ]
    fasting plasma glucose variation coefficient (CV-FPG)
  • Glucose fluctuation [ Time Frame: 6 months ]
    Largest amplitude of Glycemic Excursions (LAGE)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Disability and health-related quality of life after stroke [ Time Frame: 6 months ]
    The Stroke Impact Scale (SIS) is a specific scale that evaluates disability and health-related quality of life after stroke. This scale includes the following eight domains: strength, memory, thinking, emotion, communication and ADLs, mobility, hand function and participation. A total of 8 domains with 59 items, are scored on a 5-point scale, of which the sixth, eighth, and ninth questions of the emotional dimension are reversed, and the other items are positive. Each domain scores range from 0 to 100 and are calculated using the following equation: Calculated score=[(actual score- the lowest possible score in this domain) / (the difference between the highest possible score and the lowest score in this domain)]×100. The total score of the scale is the sum of all domains. A higher score indicates better quality of life and the less functional damage.
  • Independent living skills [ Time Frame: 6 months ]
    The Modified Rankin Scale can discriminate clinically relevant levels of disability and recovery in clinical trials. The 0-6 Likert scale is as follows: 0-no symptoms; 1-no significant disability; 2-slight disability; 3-moderate disability; 4-moderately severe disability; 5-severe disability; and 6-dead. The higher the score, the worse the patient's prognosis. When evaluating prognosis, a score≦2 was classified as a "good".
  • Glycemic control [ Time Frame: 6 months ]
    Fasting plasma glucose (FPG), 2 hours postprandial blood glucose (2hPG), hemoglobin A1c (HbA1c) will be measured at 6 months.
  • Blood lipids [ Time Frame: 6 months ]
    High-density lipoprotein-cholesterol (HDL-c), low-density lipoprotein-cholesterol (LDL-c), total cholesterol (TC), triglycerides (TG) will be measured at 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Official Title  ICMJE Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Brief Summary The present randomized control trial sought to establish glucose fluctuation as an important target for management on metabolic index, neurologic function, and quality of life in Type 2 diabetes mellitus (T2DM) patients and cerebral infarction (CI).
Detailed Description There is a significant association between glycemic fluctuation and the incidence of diabetes macrovascular complications. Therefore, understanding the impact of glycemic fluctuations on diabetic macroangiopathy could be helpful for discovering a strategy of prevention and treatment of macroangiopathy in diabetes. However, previous studies on the glycemic fluctuation in T2DM patients with CI were cross-sectional studies, there has been no prospective intervention study confirming the effects of glucose fluctuation targeted management on the prognosis of T2DM patients following CI. Based on previous fingdings, investigators will assess the effects of glucose fluctuation targeted intervention on metabolic index, neurologic function, and quality of life in T2DM patients and CI.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes and Cerebral Infarction
Intervention  ICMJE
  • Behavioral: Control group

    During hospitalization:

    1. Monitor subjects' blood glucose;
    2. One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations;
    3. Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose.

    During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge.

    Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month.

  • Behavioral: Glucose fluctuation targeted intervention
    We set achieving goals for this intervention group (both A1c<7% and LAGE<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.
Study Arms  ICMJE
  • Experimental: Control group

    During hospitalization:

    1. Monitor subjects' blood glucose;
    2. One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations;
    3. Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose.

    During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge.

    Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month.

    Intervention: Behavioral: Control group
  • Experimental: Glucose fluctuation targeted intervention
    We set achieving goals for this intervention group (both A1c<7% and LAGE<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.
    Intervention: Behavioral: Glucose fluctuation targeted intervention
Publications *
  • Wu CH, Liu B. The Fourth National Cerebrovascular Disease Conference. China Medical News (6): 4, 1996.
  • Colman PG, Thomas DW, Zimmet PZ, Welborn TA, Garcia-Webb P, Moore MP. New classification and criteria for diagnosis of diabetes mellitus. The Australasian Working Party on Diagnostic Criteria for Diabetes Mellitus. N Z Med J. 1999 Apr 23;112(1086):139-41.
  • Lou Q, Yuan X, Hao S, Miller JD, Yan J, Zuo P, Li J, Yang L, Li H. Effects of Glucose Fluctuation Targeted Intervention on the Prognosis of Patients with Type 2 Diabetes following the First Episode of Cerebral Infarction. J Diabetes Res. 2020 Jan 28;2020:2532171. doi: 10.1155/2020/2532171. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 18, 2019
Estimated Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. cerebral infarction within one month, diagnosed by magnetic resonance imaging (MRI) or computed tomography (CT) according to 1995 acute cerebral infarction diagnosis standards promulgated by the Fourth National Cerebrovascular Disease Conference [1];
  • 2. having type 2 diabetes mellitus (as defined by the WHO diagnostic criteria in 1999) [2];

Exclusion Criteria:

  • 1. coexisting acute complications of diabetes including diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), metabolic acidosis;
  • 2. severe comorbid chronic complications of diabetes;
  • 3. active malignancy;
  • 4. subjects with mental illness and communication disorders; 5) those actively participating in other research studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932084
Other Study ID Numbers  ICMJE N2017003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lou Qingqing, Nanjing University of Traditional Chinese Medicine
Study Sponsor  ICMJE Nanjing University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qingqing Lou, director Nanjing University of Traditional Chinese Medicine
PRS Account Nanjing University of Traditional Chinese Medicine
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP