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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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Modern life is characterized by a 24-hour lifestyle in which food intake is no longer restricted to daytime. As a result, people nowadays tend to eat throughout the day. When food is being consumed the energy is both used and stored for later use. Eating for a prolonged period of time makes it unnecessary for the body to use its energy storage. It is hypothesized that the decreased use of energy stores has detrimental effects on our sugar balance, mainly on insulin sensitivity. Conversely, eating within a limited period during the day could improve insulin sensitivity in people with type 2 diabetes by an increased use of energy reserves, specifically liver sugar stores. Therefore, this study examines the effect of eating within a limited time frame during the day on insulin sensitivity and liver sugar stores of people with type 2 diabetes.
Modern life is characterized by a 24-hour lifestyle in which food intake is no longer restricted to daytime. Interestingly, the majority of people spread their food intake over ~15 hours per day. This implies that most people experience a relatively short post-absorptive (fasting) state during night time. Normally, the body relies heavily on hepatic glycogen content to provide glucose and energy during the night, and glycogen stores will therefore decrease over night. In the morning, ingested carbohydrates will be taken up rapidly to replenish glycogen stores. It is hypothesized that in people with type 2 diabetes mellitus (T2DM) hepatic glycogen stores may not fully deplete overnight and that restricting food to a shorter period of time during the day will lead to a reduction of hepatic glycogen stores, and thereby improve whole-body insulin sensitivity at the beginning of the day. Therefore, the aim of this study is to investigate if time restricted feeding (TRF) leads to a reduction in overnight-fasted hepatic glycogen stores and improvement in insulin sensitivity in adults with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Feeding | Experimental | Participants are instructed to eat within a limited time frame during the day. They are also instructed to keep record of their eating and sleeping record with eat- and sleep diaries. |
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| Control | Other | Participants are instructed to spread their habitual food intake over at least 14hrs per day. They are also instructed to keep record of their eating and sleeping record with eat- and sleep diaries. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted feeding | Behavioral | Eating within a time frame of 10hrs during the day. Outside of this time frame, participants need to refrain from food and energy containing drinks. |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic glycogen | 13C-Magnetic Resonance Spectrometry | Measurement performed after 3 weeks of intervention/control |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Two-steps hyperinsulinaemic clamp | Measurement performed after 3 weeks of intervention/control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Schrauwen, Prof. Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 6229ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35871650 | Derived | Andriessen C, Fealy CE, Veelen A, van Beek SMM, Roumans KHM, Connell NJ, Mevenkamp J, Moonen-Kornips E, Havekes B, Schrauwen-Hinderling VB, Hoeks J, Schrauwen P. Three weeks of time-restricted eating improves glucose homeostasis in adults with type 2 diabetes but does not improve insulin sensitivity: a randomised crossover trial. Diabetologia. 2022 Oct;65(10):1710-1720. doi: 10.1007/s00125-022-05752-z. Epub 2022 Jul 25. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomised controlled cross-over design with two 3-week arms and a 4-week wash-out period.
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Due to the nature of this study, it is not possible to mask the intervention effect for the investigator or the participant. During randomisation, the intervention arms will be coded with 1 and 2 and the independent researcher will be unaware which intervention is assigned to which letter. With this approach, concealed allocation will be guaranteed. Additionally, the person in charge with the data quality check and the data analyses will be blinded for the interventions using this same randomisation codes to generate unbiased results.
| Control | Behavioral | Eating for at least 14hrs per day. |
|
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |