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A study to evaluate the impact of glucose variability on cardiovascular disease, sleep disorder, and diabetic complications

A study to evaluate the impact of glucose variability on cardiovascular disease, sleep disorder, and diabetic complications in patients with type 2 diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006171
Enrollment
110
Registered
2021-05-24
Start date
2021-11-09
Completion date
Unknown
Last updated
2021-12-02

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

Conditions

None listed

Interventions

None listed

Sponsors

Korea University Ansan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ° Patients with type 2 diabetes aged 19 to 80 years, and who will be treated with the following insulin and oral hypoglycemic medications. - Basal insulin: Levemir, Lantus, Tresiba, Toujeo - Prandial insulin: NovoRapid, Fiasp, Humalog, Apidra - Premixed insulin: Ryzodeg ° Hypoglycemic agents other than insulin - Metformin, Thiazolidinedione (Pioglitazone, Lobeglitazone, Rosiglitazone), Sulfonylurea (Glimepiride, Gliclazide, Glipizide, Glibenclamide), Meglitinide (Repaglinide, Nateglinide, Mitiglinide), DPP4 inhibitor (Sitagliptin, Linagliptin, Gemigliptin, Vildagliptin, Saxagliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin), GLP-1 agonist (Exenatide, Lixisenatide, Liraglutide, Exenatide LAR, Albiglutide, Dulaglutide), SGLT-2 inhibitor (Dapagliflozin, Empagliflozin, Ipragliflozin), a-glucosidase Inhibitor (Acarbose, Voglibose) ° Fasting C-peptide level measured at the hospital in the past 2 years is 0.4-3.0ng/mL

Exclusion criteria

Exclusion criteria: Those who fall under any of the following criteria ° Insulin pump users ° Those who have been hospitalized for HHS (hyperglycemia hyperosmolar syndrome), DKA (Diabetic ketoacidosis), acute myocardial infarction, or stroke in the past 3 months ° Stage 4 or 5 of chronic renal disease (< eGFR 30) ° Patients with hepatic failure (AST or ALT = 2.5 times the upper normal limit) or symptomatic heart failure with pulmonary oedema ° Those who are currently receiving anticancer therapy, radiation therapy, and targeted therapy ° Those who are currently receiving the following medicines that may affect blood glucose - Steroid, immunosuppressive agents (cyclosporine, tacrolimus, and sirolimus), nicotinic acid =1500mg/day, systemic isotretinoin, and anti-obesity agents (liraglutide, orlistat, phentermine, phendimetrazine, mazindol) - Route of steroid administration: Oral administration and intravenous injection and joint injection are excluded from the study (A nasal spray or inhaler at maintenance dose may be used in this study) ° Patients with uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg) ° Pregnant or lactating women ° Those who are determined to be not eligible for this study in the judgment of the investigator

Design outcomes

Primary

MeasureTime frame
correlation between glucose variability and whether hypoglycemia occurred

Secondary

MeasureTime frame
correlation between glucose variability and whether diabetic complications (diabetic retinopathy, renal disease, and neuropathy) occurred concurrently ;correlation between glucose variability and whether cardiovascular diseases occurred concurrently ;correlation between glucose variability and insulin resistance;correlation between glucose variability and heart rate variability ;correlation between glucose variability and muscle mass;correlation between glucose variability and blood pressure variability ;correlation between glucose variability and heart function ;correlation between glucose variability and sleep habit;correlation between glucose variability and circadian rhythm;correlation between glucose variability and thyroid function test

Countries

Korea, Republic of

Contacts

Public ContactDa Young Lee

Korea University Ansan Hospital

ddkristin412@gmail.com+82-31-412-4822

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026