None listed
Conditions
Interventions
Behavioral : This is an open-label, randomized clinical trial. Participants will be randomly assigned in a 1:1 ratio to either Group A or Group B. Following a 10-day baseline study prior to randomizat
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with type 2 diabetes mellitus - Aged between 19 and 70 years - Hemoglobin A1c level between 6.5% and 11% within two months prior to study enrollment - On no more than four types of oral hypoglycemic agents (excluding insulin users) - No significant weight change (=4%) within three months prior to study participation - No food allergies to soy or nuts
Exclusion criteria
Exclusion criteria: - Diagnosed with type 1 diabetes mellitus - Using an insulin - Body Mass Index (BMI) below 23 kg/m² - Night shift worker - Existing eating window (time between the first and last meal) less than 10 hours - History of eating disorders (anorexia, bulimia, or binge eating disorder) - Hospitalization within the last three months due to HHS (hyperglycemic hyperosmolar syndrome), DKA (diabetic ketoacidosis), acute myocardial infarction, or stroke - Stage 4 or 5 chronic kidney disease (eGFR 2.5 times the upper normal limit) or heart failure with pulmonary edema - Currently undergoing cancer treatments, such as chemotherapy, radiotherapy, or targeted therapy - Taking medications that may affect blood glucose levels, including: - Steroids, immunosuppressants (cyclosporine, tacrolimus, sirolimus), nicotinic acid =1500mg/day, systemic isotretinoin, or obesity medications (liraglutide, orlistat, phentermine, phendimetrazine, mazindol) - Excluded routes for steroids: oral, intravenous, or joint injections (maintenance nasal spray or inhaler use is allowed) - Uncontrolled hypertension (SBP =180 mmHg or DBP =100 mmHg) - Uncontrolled thyroid dysfunction (TSH =10 or Diagnosis of Graves' ds withing 3 months) - Pregnant or breastfeeding - Any other condition deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in time in range (70-180 mg/dL, %) measured by CGM at V3 visit between Group A and Group B | — |
Secondary
| Measure | Time frame |
|---|---|
| The differences between Group A and Group B in other CGM metrics (time in tight range 70-140 mg/dL, time above range >180 mg/dL, time above range >250 mg/dL, time below range <70 mg/dL, time below range <55 mg/dL, %CV, SD), HbA1c, fructosamine, glycoalbumin, lipid profile (total cholesterol, triglycerides, HDL, LDL), free fatty acids, weight, BMI, body composition, gut microbiome, MES, circadian rhythm markers (amplitude, acrophase, mesor, goodness of fit, heart rate), diabetes self-management indicators, sleep quality index, and social jetlag.;In Group A, the changes from baseline in CGM metrics, HbA1c, fructosamine, glycoalbumin, lipid profile, free fatty acids, weight, BMI, body composition, gut microbiome, MES, circadian rhythm markers, diabetes self-management indicators, sleep quality index, and social jetlag at the end of study ;The difference in the incidence of hypoglycemia (<70 mg/dL) and severe hypoglycemia (<54 mg/dL), as well as allergic reactions, between Group A and Group B during study. | — |
Countries
Korea, Republic of
Contacts
Public ContactNan Hee Kim
Korea University Ansan Hospital
Outcome results
None listed