|
Restricted Eating Time in the Treatment of Type 2 Diabetes
RECRUITINGN/ASponsored by Steno Diabetes Center Copenhagen
Actively Recruiting
PhaseN/A
SponsorSteno Diabetes Center Copenhagen
Started2024-03-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06152588
Summary
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).
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
DiabetesType 2 Diabetes
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorSteno Diabetes Center Copenhagen
Started2024-03-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06152588