Impaired fasting glucose (IFG) or type 2 diabetes (T2D) time-restricted eating, shift workers, impaired fasting glucose , type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Confirmed diagnosis of IFG or T2D at least 6 months before enrollment 2. Age 18 - 65 years 3. HbA1c below 8.5% (measured within the past 3 months) 4. Glycemic management without insulin or sulfonylureas (allowed: diet control, Metformin, Pioglitazone, DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists at stable doses for more than 8 weeks). 5. Current Ramathibodi Hospital night-shift staff who are recruited via paper posters, electronic posters, or department representatives, and are willing to participate in the study. 6. Have engaged in night-shift work for at least two periods, with each period comprising at least three consecutive night shifts
Exclusion criteria
Exclusion criteria: 1. Inability to adhere to the restricted eating window 2. Diagnosed Eating disorders or major psychiatric disorders 3. Unable or unwilling to use CGM 4. Current systemic corticosteroid therapy or within the past 4 weeks 5. Alcohol misuse 6. Pregnancy, lactation or planning pregnancy during the study 7. Chronic kidney disease with eGFR < 45 8. Cirrhosis (Child-Pugh B or C) or investigator-judged clinically significant liver dysfunction 9. Active cardiovascular disease: acute coronary syndrome, decompensated heart failure, clinically significant arrhythmia, stroke, or coronary revascularization within the past 3 months before enrolment 10. History of severe hypoglycemia (loss of consciousness, requiring assistance) within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent time in range (TIR) Averaged over three consecutive study days, comparing within-subject values between the night-time fasting and night-time meal condition. Continuous glucose monitoring (CGM) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental area under the glucose curve (iAUC) From 0 to 120 minutes following the MMTT at the end of each treatment period Calculation from blood test result at 0 to 120 minutes following the mixed-meal tolerance test (MMTT),Homeostatic model assessment of insulin resistance (HOMA-IR) From 0 to 120 minutes following the MMTT at the end of each treatment period Calculation from blood test result at 0 to 120 minutes following the mixed-meal tolerance test (MMTT),Matsuda insulin sensitivity index (Matsuda ISI) From 0 to 120 minutes following the MMTT at the end of each treatment period Calculation from blood test result at 0 to 120 minutes following the mixed-meal tolerance test (MMTT),Insulinogenic index (IGI) From 0 to 120 minutes following the MMTT at the end of each treatment period Calculation from blood test result at 0 to 120 minutes following the mixed-meal tolerance test (MMTT),Oral disposition index (oDI) From 0 to 120 minutes following the MMTT at the end of each treatment period Calculation from blood test result at 0 to 120 minutes following the mixed-meal tolerance test (MMTT),Other CGM metrics Averaged over three consecutive study days, comparing within-subject values between the night-time fasting and night-time meal condition. Percent time above range (TAR), coefficient of variation (%CV),Cardiometabolic and inflammatory markers At the end of each treatment period Lipid profile, blood pressure, C-reactive protein,Safety outcomes Averaged over three consecutive study days, comparing within-subject values between the night-time fasting and night-time meal condition. Percent time below range (TBR) | — |
Countries
Thailand
Contacts
Mahidol university