Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.
TRF
Effect of Time Restricted Feeding on Hepatic Glycogen Depletion and Insulin Sensitivity in Adults With Type 2 Diabetes
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2021
CompletedFebruary 9, 2021
February 1, 2021
2 years
June 18, 2019
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatic glycogen
13C-Magnetic Resonance Spectrometry
Measurement performed after 3 weeks of intervention/control
Secondary Outcomes (1)
Insulin sensitivity
Measurement performed after 3 weeks of intervention/control
Study Arms (2)
Time Restricted Feeding
EXPERIMENTALParticipants 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.
Control
OTHERParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, Limburg, 6229ER, Netherlands
Related Publications (1)
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.
PMID: 35871650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Schrauwen, Prof. Dr.
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 20, 2019
Study Start
January 31, 2019
Primary Completion
February 3, 2021
Study Completion
February 3, 2021
Last Updated
February 9, 2021
Record last verified: 2021-02