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Restricted Eating Time in the Treatment of Type 2 Diabetes

The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).

ClinicalTrials.gov IDNCT06152588
PhaseNA
Enrollment160
SponsorSteno Diabetes Center Copenhagen
Age18 Years
SexALL
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Conditions studied

Type 2 Diabetes

About this study

The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Age: ≥18 years * Overweight or obesity (BMI ≥25 kg/m2) * T2D with HbA1c\>53 mmol/mol * Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages) Exclusion Criteria: * Bariatric surgery or planned bariatric surgery within study duration * Use of fast acting insulin and combination insulin products * Habitual CGM use * A wish to adhere to Ramadan * For women: current/planned pregnancy or lactation * Alcohol or drug abuse (judged by investigator) or treatment with disulfiram * Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery) * Inability to understand written and oral information in Danish * Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions. * Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic, or endocrine diseases etc. * Concomitant participation in other intervention study * Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.) Exclusion criteria for the sub-study: * Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and severe claustrophobia * Participants who do not wish to be informed about accidental findings by MR.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.