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Effects of Time-Restricted Eating on Glycemic Control in Night-Shift Workers With Impaired Fasting Glucose or Type 2 Diabetes: A Randomized Crossover Trial

Effects of Time-Restricted Eating on Glycemic Control in Night-Shift Workers With Impaired Fasting Glucose or Type 2 Diabetes: A Randomized Crossover Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260417011
Enrollment
25
Registered
2026-04-17
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Impaired fasting glucose (IFG) or type 2 diabetes (T2D) time-restricted eating, shift workers, impaired fasting glucose , type 2 diabetes

Interventions

Time-restricted eating with night-time fasting for three consecutive days of night-shift work per monthly duty cycle.,Night-time eating with the same total daily energy intake as the intervention ove
Experimental Behavioral,No Intervention Behavioral
Night-time fasting,Night-time eating

Sponsors

Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactKitti Thammakosol

Mahidol university

Kitti.tha@mahidol.ac.th0816498718

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026