Clinical trial NCT03992248: Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.
Official title: Effect of Time Restricted Feeding on Hepatic Glycogen Depletion and Insulin Sensitivity in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: TRF
Hepatic glycogen
Type 2 diabetes
Insulin sensitivity
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2019-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised controlled cross-over design with two 3-week arms and a 4-week wash-out period.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Caucasian
* Non-insulin treated type 2 diabetes,
* BMI: \>25 kg/m2
* Regular sleeping time (normally 7 - 9 hrs daily)
* Habitual bedtime at 11 PM plus/minus 2 hours

Exclusion Criteria:

* Not being able to adhere to a restricted feeding schedule
* Uncontrolled hypertension
* Active cardiovascular disease
* Insulin therapy
* Use of SGLT2 inhibitors
* BMI\>38 kg/m2
* Engaged in programmed exercise for \>3hrs per week
* Extreme early bird or extreme night person
* Heavily varying sleep-wake rhythm
* Shiftwork during last 3 months
* Smoking
* Contra-indication to MRI scanning
* Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention
* Subjects who do not want to be informed about unexpected medical findings during the screening/study, or do not wish that their physician is informed
* Unstable body weight (weight gain or loss \>3kg in the last 3 months)
* Significant food allergies/intolerance (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results
* Any other medical condition that will preclude the safe performance of the measurements

Primary outcomes:
measure: Hepatic glycogen
timeFrame: Measurement performed after 3 weeks of intervention/control
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: Measurement performed after 3 weeks of intervention/control
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Patrick Schrauwen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.