Trial Outcomes & Findings for TRE in Type 2 Diabetes (See Food Study 3) (NCT NCT05290246)
NCT ID: NCT05290246
Last Updated: 2026-04-14
Results Overview
Change in hemoglobin A1c
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
Time Restricted Eating
daily 8 hour eating window
Time restricted eating: Limiting daily eating time to an 8 hour window
|
Caloric Restriction
reduction of caloric intake by 15%
Caloric reduction: Cut caloric intake by 15%
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TRE in Type 2 Diabetes (See Food Study 3)
Baseline characteristics by cohort
| Measure |
Time Restricted Eating
n=32 Participants
daily 8 hour eating window
Time restricted eating: Limiting daily eating time to an 8 hour window
|
Caloric Restriction
n=32 Participants
reduction of caloric intake by 15%
Caloric reduction: Cut caloric intake by 15%
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 7.4 • n=193 Participants
|
54.2 years
STANDARD_DEVIATION 9.3 • n=193 Participants
|
54.6 years
STANDARD_DEVIATION 8.3 • n=386 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
24 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=193 Participants
|
20 Participants
n=193 Participants
|
40 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=193 Participants
|
27 Participants
n=193 Participants
|
57 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange in hemoglobin A1c
Outcome measures
| Measure |
Time Restricted Eating
n=29 Participants
daily 8 hour eating window
Time restricted eating: Limiting daily eating time to an 8 hour window
|
Caloric Restriction
n=29 Participants
reduction of caloric intake by 15%
Caloric reduction: Cut caloric intake by 15%
|
|---|---|---|
|
Change in Glycemic Measures- HbA1c (12w)
|
-0.22 percentage of glycated hemoglobin
Standard Deviation 0.53
|
-0.25 percentage of glycated hemoglobin
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 12 weeksChange in weight from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksChange in weight from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksChange in fasting insulin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksChange in fasting insulin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksChange in Homeostatic Model Assessment for Insulin Resistance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksChange in fasting Homeostatic Model Assessment for Insulin Resistance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksChange in hemoglobin A1c
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksChange in continuous glucose monitoring
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksChange in continuous glucose monitoring
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksParticipant self-report via survey
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksParticipant self-report via survey
Outcome measures
Outcome data not reported
Adverse Events
Time Restricted Eating
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Caloric Restriction
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Time Restricted Eating
n=32 participants at risk
daily 8 hour eating window
Time restricted eating: Limiting daily eating time to an 8 hour window
|
Caloric Restriction
n=32 participants at risk
reduction of caloric intake by 15%
Caloric reduction: Cut caloric intake by 15%
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • Month 6
|
0.00%
0/32 • Month 6
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Number of events 1 • Month 6
|
0.00%
0/32 • Month 6
|
|
Gastrointestinal disorders
Loose stool
|
3.1%
1/32 • Number of events 1 • Month 6
|
0.00%
0/32 • Month 6
|
|
Renal and urinary disorders
Pyelonephritis
|
3.1%
1/32 • Number of events 1 • Month 6
|
0.00%
0/32 • Month 6
|
|
Cardiac disorders
Chest pain
|
0.00%
0/32 • Month 6
|
3.1%
1/32 • Number of events 1 • Month 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place