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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
German Institute of Human Nutrition Potsdam-Rehbruecke
RECRUITING
Nuthetal
Contact Information
Primary
Olga Ramich, Prof. Dr.
olga.ramich@dife.de
+49 33200 882749
Backup
Bettina Schuppelius, M.Sc.
bettina.schuppelius@dife.de
+49 33200 882692
Time Frame
Start Date: 2025-09-19
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 30
Treatments
Experimental: Early Time-Restricted Eating
Experimental: Late Time-Restricted Eating
Related Therapeutic Areas
Sponsors
Collaborators: Technische Universität München, Germany, German Diabetes Center (DDZ), Germany, University of Surrey, UK, University of Rovira i Virgili, Spain, University of Geneva, Switzerland, Technische Universität Dresden, Germany
Leads: German Institute of Human Nutrition

This content was sourced from clinicaltrials.gov