Time-restricted eating for managing type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a one-year time-restricted eating (TRE) intervention on glycaemic control, body weight, and cardiometabolic risk factors in individuals with type 2 diabetes who are overweight or obese. The approach aims to address the challenges of traditional dietary interventions by tailoring the program to individual needs and promoting sustainable lifestyle changes. Participants will follow a structured eating schedule to potentially improve their health outcomes and reduce reliance on diabetes medications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Steno Diabetes Center Copenhagen
  Herlev, Denmark, Denmark Recruiting

Study contacts

• Principal investigator: Jonas S Quist, PhD — Steno Diabetes Center Copenhagen
• Study coordinator: Jonas S Quist, PhD
• Email: jonas.salling.quist@regionh.dk
• Phone: +45 26176064

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.