Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus

Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus - Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cognitive Function in Elderly Patients with Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038546

Enrollment

120

Registered

2019-11-11

Start date

2019-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 Diabetes Mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)patients with type 2 diabetes mellitus who are treated at National Cerebral and Cardiovascular Center. 2)patients who receive sulphonylurea, glinide and/or insulin, or patients with HbA1c7.0% or more who receive other oral hypoglycemic agents and/or glucagon-like peptide 1 receptor agonist. 3)the Montreal Cognitive Assessment (MoCA) score is between 17 and 25.

Exclusion criteria

Exclusion criteria: 1)undergoing renal replacement therapy. 2)receiving therapy for malignancy 3)taking antidementia drugs or underlying comorbidities affecting cognitive function (depression, thyroid dysfunction or deficiency of vitamin B1, B12 or folate). 4)carotid-artery stenosis greater than 80% luminal area. 5)judged as inappropriate by the clinical investigators.

Design outcomes

Primary

Measure	Time frame
The relationships between the indexes obtained from CGM (Libre Pro) data and the change of score of Montreal Cognitive Assessment and Alzheimer's Disease Assessment Scale.	—

Secondary

Measure	Time frame
1)Development of CV event; cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization due to unstable angina pectoris or heart failure, or myocardial revascularization. 2)Development of renal event; progression of diabetic kidney disease stage, initiation of renal replacement therapy or doubling of the serum creatinine level from baseline. 3)Changes of Brain Observer Micro Bleed Scale (BOMBS), Fazekas scale, Cerebral small vessel disease (SVD) score and % stenosis of intracranial artery assessed by WASID method. These parameters are obtained by MRI and MRA of the head. 4)Changes of GDS and Apathy scale. 5)Changes of Morisky score. 6)Changes of intima-media thickness (IMT) in the distal wall of both common carotid arteries at 1 centimeter from bifurcation assessed by carotid artery echography. 7)Changes of hs-CRP and IL-6. 8)Changes in fasting glucose and HbA1c. 9)Changes in blood pressure.	—

Measure

Time frame

1)Development of CV event; cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization due to unstable angina pectoris or heart failure, or myocardial revascularization. 2)Development of renal event; progression of diabetic kidney disease stage, initiation of renal replacement therapy or doubling of the serum creatinine level from baseline. 3)Changes of Brain Observer Micro Bleed Scale (BOMBS), Fazekas scale, Cerebral small vessel disease (SVD) score and % stenosis of intracranial artery assessed by WASID method. These parameters are obtained by MRI and MRA of the head. 4)Changes of GDS and Apathy scale. 5)Changes of Morisky score. 6)Changes of intima-media thickness (IMT) in the distal wall of both common carotid arteries at 1 centimeter from bifurcation assessed by carotid artery echography. 7)Changes of hs-CRP and IL-6. 8)Changes in fasting glucose and HbA1c. 9)Changes in blood pressure.

—

Countries

Japan

Contacts

Public ContactMatsubara Masaki

National Cerebral and Cardiovascular Center Division of Diabetes and Lipid Metabolism

matsubara.m@ncvc.go.jp0661701070

Outcome results