NCT03932084

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

April 23, 2019

Last Update Submit

April 25, 2019

Conditions

Type 2 Diabetes and Cerebral Infarction

Keywords

Type 2 diabetesCerebral infarctionGlucose fluctuation targeted intervention

Outcome Measures

Primary Outcomes (3)

  • 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).

    6 months

  • Glycemic variability

    fasting plasma glucose variation coefficient (CV-FPG)

    6 months

  • Glucose fluctuation

    Largest amplitude of Glycemic Excursions (LAGE)

    6 months

Secondary Outcomes (4)

  • Disability and health-related quality of life after stroke

    6 months

  • Independent living skills

    6 months

  • Glycemic control

    6 months

  • Blood lipids

    6 months

Study Arms (2)

Control group

EXPERIMENTAL

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

Glucose fluctuation targeted intervention

EXPERIMENTAL

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

Interventions

Glucose fluctuation targeted interventionBEHAVIORAL

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.

Glucose fluctuation targeted intervention
Control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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 \[1\];
  • \. having type 2 diabetes mellitus (as defined by the WHO diagnostic criteria in 1999) \[2\];

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210028, China

RECRUITING

Related Publications (3)

  • Wu CH, Liu B. The Fourth National Cerebrovascular Disease Conference. China Medical News (6): 4, 1996.

    BACKGROUND

  • 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.

    PMID: 10340693BACKGROUND

  • 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.

    PMID: 32090117DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cerebral Infarction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Qingqing Lou, director

    Nanjing University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingqing Lou, director

CONTACT

8615312019129lqq188@yahoo.com

Juan Yan

CONTACT

86135852089101678451162@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Education Department

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 30, 2019

Study Start

February 1, 2017

Primary Completion

May 25, 2019

Study Completion

June 18, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

CN(1)