Back to resultsEffects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Primary Purpose
Type 2 Diabetes and Cerebral Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Control group
Glucose fluctuation targeted intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes and Cerebral Infarction focused on measuring Type 2 diabetes, Cerebral infarction, Glucose fluctuation targeted intervention
Eligibility 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.
Sites / Locations
- Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Glucose fluctuation targeted intervention
Arm Description
During hospitalization: Monitor subjects' blood glucose; 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; 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.
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.
Outcomes
Primary Outcome Measures
Stroke severity
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
fasting plasma glucose variation coefficient (CV-FPG)
Glucose fluctuation
Largest amplitude of Glycemic Excursions (LAGE)
Secondary Outcome Measures
Disability and health-related quality of life after stroke
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
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
Fasting plasma glucose (FPG), 2 hours postprandial blood glucose (2hPG), hemoglobin A1c (HbA1c) will be measured at 6 months.
Blood lipids
High-density lipoprotein-cholesterol (HDL-c), low-density lipoprotein-cholesterol (LDL-c), total cholesterol (TC), triglycerides (TG) will be measured at 6 months.
Full Information
NCT ID
NCT03932084
First Posted
April 23, 2019
Last Updated
April 25, 2019
Sponsor
Nanjing University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03932084
Brief Title
Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Official Title
Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 25, 2019 (Anticipated)
Study Completion Date
June 18, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes and Cerebral Infarction
Keywords
Type 2 diabetes, Cerebral infarction, Glucose fluctuation targeted intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
During hospitalization:
Monitor subjects' blood glucose;
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;
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.
Arm Title
Glucose fluctuation targeted intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
During hospitalization:
Monitor subjects' blood glucose;
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;
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 Type
Behavioral
Intervention Name(s)
Glucose fluctuation targeted intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke severity
Description
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).
Time Frame
6 months
Title
Glycemic variability
Description
fasting plasma glucose variation coefficient (CV-FPG)
Time Frame
6 months
Title
Glucose fluctuation
Description
Largest amplitude of Glycemic Excursions (LAGE)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disability and health-related quality of life after stroke
Description
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.
Time Frame
6 months
Title
Independent living skills
Description
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".
Time Frame
6 months
Title
Glycemic control
Description
Fasting plasma glucose (FPG), 2 hours postprandial blood glucose (2hPG), hemoglobin A1c (HbA1c) will be measured at 6 months.
Time Frame
6 months
Title
Blood lipids
Description
High-density lipoprotein-cholesterol (HDL-c), low-density lipoprotein-cholesterol (LDL-c), total cholesterol (TC), triglycerides (TG) will be measured at 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Lou, director
Phone
8615312019129
Email
lqq188@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Yan
Phone
8613585208910
Email
1678451162@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Lou, director
Organizational Affiliation
Nanjing University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shujie Hao
Phone
8613852293808
Email
1195286284@qq.com
First Name & Middle Initial & Last Name & Degree
Juan Yan
Phone
8613585208910
Email
1678451162@qq.com
12. IPD Sharing Statement
Citations:
Citation
Wu CH, Liu B. The Fourth National Cerebrovascular Disease Conference. China Medical News (6): 4, 1996.
Results Reference
background
PubMed Identifier
10340693
Citation
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.
Results Reference
background
PubMed Identifier
32090117
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction
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