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Recruiting NCT07171281

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

No phase Interventional Prediabetes Type 2 Diabetes Obesity &Amp; Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Time-Restricted Eating, Late Time-Restricted Eating.
Who it may be relevant to
Registry conditions: Prediabetes, Type 2 Diabetes, Obesity &Amp; Overweight. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial

Overview

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.

Interventions

  • Behavioral Early Time-Restricted Eating
    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 calori
  • Behavioral Late Time-Restricted Eating
    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

Primary outcome measures

  • Mean 24-hour glucose [Time frame: 5 weeks]
Secondary outcome measures (12)
  • Glycemic variability [Time frame: 5 weeks]
  • Glucose levels [Time frame: 5 weeks]
  • Insulin levels [Time frame: 5 weeks]
  • Glucagon levels [Time frame: 5 weeks]
  • Insulin resistance [Time frame: 5 weeks]
  • Insulin secretion [Time frame: 5 weeks]
  • Body weight [Time frame: 5 weeks]
  • Body Mass Index (BMI) [Time frame: 5 weeks]
  • Waist and hip circumference [Time frame: 5 weeks]
  • Body composition [Time frame: 5 weeks]
  • Fasting cholesterol [Time frame: 5 weeks]
  • Fasting triglycerides [Time frame: 5 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal

Identifiers

NCT: NCT07171281 · 85/2023 · TEMP643937-BO-ff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗