Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes
GLYCOTIME
2 other identifiers
interventional
30
1 country
1
Brief Summary
The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedStudy Start
First participant enrolled
September 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
September 12, 2025
September 1, 2025
2.3 years
August 26, 2025
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean 24-hour glucose
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
5 weeks
Secondary Outcomes (32)
Glycemic variability
5 weeks
Glucose levels
5 weeks
Insulin levels
5 weeks
Glucagon levels
5 weeks
Insulin resistance
5 weeks
- +27 more secondary outcomes
Other Outcomes (5)
Physical activity level
5 weeks
Liver enzyme levels and renal values
5 weeks
Food intake
5 weeks
- +2 more other outcomes
Study Arms (2)
Early Time-Restricted Eating
EXPERIMENTALLate Time-Restricted Eating
EXPERIMENTALInterventions
Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the early TRE intervention, participants will primarily consume their meals in the morning. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate caloric restriction.
Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the late TRE intervention, participants will primarily consume their meals in the evening. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate caloric restriction.
Eligibility Criteria
You may qualify if:
- Overweight or obesity (BMI 25-40 kg/m²)
- Healthy glucose metabolism (fasting glucose \<100 mg/dl and glucose after 2 hours OGTT \<140 mg/dl)
- OR impaired glucose metabolism (fasting glucose 100-125 mg/dl and/or glucose after 2 hours OGTT 140-199 mg/dl and/or HbA1c 5.7-6.4%)
- OR type 2 diabetes (according to existing medical diagnosis or fasting glucose \>126 mg/dl and/or glucose after 2 hours OGTT \>200 mg/dl and/or HbA1c ≥6.5%)
- Daily eating window ≥12 hours
You may not qualify if:
- Weight changes \> 5% within past 3 months
- Shift work
- Traveling across more than one time zone within one month prior to the study
- Pregnancy and breastfeeding
- Eating disorders, food intolerance/allergy to ingredients in the diet product, vegan diet, practicing time-restricted eating
- Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes, recent cardiovascular event, malabsorption, cancer in the last two years, etc.)
- Treatment with insulin, sulfonylureas, and GLP-1 receptor agonists, steroid use (oral, cutaneous, or parenteral), regular intake of melatonin, anticoagulation treatment that cannot be paused
- Extreme early and extreme late chronotypes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Institute of Human Nutritionlead
- Technische Universität Dresden, Germanycollaborator
- University of Surrey, UKcollaborator
- University of Geneva, Switzerlandcollaborator
- Technische Universität München, Germanycollaborator
- German Diabetes Center (DDZ), Germanycollaborator
- University of Rovira i Virgili, Spaincollaborator
Study Sites (1)
German Institute of Human Nutrition Potsdam-Rehbruecke
Nuthetal, 14558, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department Molecular Metabolism and Precision Nutrition
Study Record Dates
First Submitted
August 26, 2025
First Posted
September 12, 2025
Study Start
September 19, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share