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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03932084

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

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:Type 2 Diabetes and Cerebral Infarction
  • Intervention/Treatment: Behavioral: Control group
    Behavioral: Glucose fluctuation targeted intervention
  • Phase: N/A
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
  • Study Type: Interventional
  • 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 2017
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: June 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Control group
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.
Behavioral: Control group
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.
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
  • 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

Contact: Qingqing Lou, director 8615312019129 lqq188@yahoo.com

Contact: Juan Yan 8613585208910 1678451162@qq.com

Locations

China, Jiangsu
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
Nanjing

Sponsors and Collaborators

Nanjing University of Traditional Chinese Medicine

Investigators

Principal Investigator: Qingqing Lou, director Nanjing University of Traditional Chinese Medicine

More Information