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Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes

RECRUITINGN/ASponsored by German Institute of Human Nutrition
Actively Recruiting
PhaseN/A
SponsorGerman Institute of Human Nutrition
Started2025-09-19
Est. completion2027-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions4

DiabetesObesity &Amp; OverweightPreDiabetesType 2 Diabetes

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