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

Recruiting now · Not applicable

Conditions studied: Prediabetes, Type 2 Diabetes, Obesity &Amp; Overweight

In brief

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.

Key facts

Study ID

NCT07171281

Run by

German Institute of Human Nutrition

People needed

30

Starts

2025-09-19

Expected to finish

2028-02-28

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal, Germany (enrolling)

Full record on ClinicalTrials.gov

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