Time-restricted eating for managing type 2 diabetes
Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.
This study tests if a one-year time-restricted eating plan can help people with type 2 diabetes who are overweight or obese manage their blood sugar, lose weight, and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Herlev, Denmark) |
| Trial ID | NCT06152588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes, a BMI of 25 kg/m² or higher, and a habitual eating window of at least 12 hours per day.
Not a fit: Patients who have had bariatric surgery, use fast-acting insulin, or have severe hypoglycaemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved glycaemic control and weight management for patients with type 2 diabetes.
How similar studies have performed: Previous studies on intermittent fasting and lifestyle interventions have shown promise in improving metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herlev, Denmark
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.