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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

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

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