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

German Institute of Human Nutrition

Status

Enrolling

Conditions

Obesity &Amp; Overweight

Prediabetes

Type 2 Diabetes

Treatments

Behavioral: Early Time-Restricted Eating

Behavioral: Late Time-Restricted Eating

Study type

Interventional

Funder types

Other

Identifiers

NCT07171281

TEMP643937-BO-ff (Other Identifier)

85/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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