Clinical trial NCT03932084: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes and Cerebral Infarction
Keywords: Type 2 diabetes
Cerebral infarction
Glucose fluctuation targeted intervention
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stroke severity
timeFrame: 6 months
measure: Glycemic variability
timeFrame: 6 months
measure: Glucose fluctuation
timeFrame: 6 months
Secondary outcomes:
measure: Disability and health-related quality of life after stroke
timeFrame: 6 months
measure: Independent living skills
timeFrame: 6 months
measure: Glycemic control
timeFrame: 6 months
measure: Blood lipids
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Nanjing University of Traditional Chinese Medicine
name: Qingqing Lou, director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CH, Liu B. The Fourth National Cerebrovascular Disease Conference. China Medical News (6): 4, 1996.
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.
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.