Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean 24-hour glucose
Study Overview
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.
Detailed Description
This dietary intervention study will follow a crossover design. During the intervention phases, participants will restrict their dietary intake to a defined eating window of 8 hours - predominantly in the morning (early TRE) or predominantly in the afternoon (late TRE) - in conjunction with a moderate caloric restriction for five weeks. A 10-12-week washout phase will separate the intervention periods.
Overweight and obese individuals with healthy glucose metabolism, prediabetes, or non-insulin-treated type 2 diabetes will be recruited for the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Arms & Interventions
Late Time-Restricted Eating
Intervention: Late Time-Restricted Eating (Behavioral)
Early Time-Restricted Eating
Intervention: Early Time-Restricted Eating (Behavioral)
Outcomes
Primary Outcomes
Mean 24-hour glucose
Time Frame: 5 weeks
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
Secondary Outcomes
- Glucagon-like peptide-1 levels(5 weeks)
- Waist and hip circumference(5 weeks)
- Body composition(5 weeks)
- Sleep and wake timing(5 weeks)
- Glycemic variability(5 weeks)
- Glucose levels(5 weeks)
- Insulin levels(5 weeks)
- Glucagon levels(5 weeks)
- Insulin resistance(5 weeks)
- Insulin secretion(5 weeks)
- Body weight(5 weeks)
- Body Mass Index (BMI)(5 weeks)
- Fasting cholesterol(5 weeks)
- Fasting triglycerides(5 weeks)
- Blood pressure(5 weeks)
- Resting energy expenditure(5 weeks)
- Gene expresssion in adipose tissue(5 weeks)
- Inflammatory markers in blood and adipose tissue(5 weeks)
- Subjective satiety and hunger sensation(5 weeks)
- Concentration of satiety and hunger regulating hormones(5 weeks)
- Species and strain-level microbiome changes(5 weeks)
- Levels of microbiome-derived metabolites(5 weeks)
- Sleep quality(5 weeks)
- Internal circadian phase(Screening visit (week 0))
- Gastric inhibitory polypeptide(5 weeks)
- Gene expresssion in peripheral mononuclear blood cells (PBMCs)(5 weeks)
- Malondialdehyde(5 weeks)
- 3-nitrotyrosine(5 weeks)
- Protein carbonyls(5 weeks)
- 36-item Short Form Health Survey (SF-36) to measure health-related quality-of-life(5 weeks)
- Satisfaction with the intervention(5 weeks)
- Decision behavior(5 weeks)
Investigators
Olga Ramich (formerly Pivovarova)
Head of Department Molecular Metabolism and Precision Nutrition
Study Sites (1)
Identifiers
- NCT ID
- NCT07171281
- Other Study IDs
- 85/2023, TEMP643937-BO-ff
Dates
- First Submitted
- (last year)
- First Posted
- (last year)
- Primary Completion
- (next year)
- Study Completion
- (next year)
- Last Verified
- (29 days ago)
- Last updated
- (yesterday)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No