Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With… (NCT03992248) | Clinical Trial Compass
CompletedNot Applicable
Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.
Netherlands21 participantsStarted 2019-01-31
Plain-language 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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hepatic glycogen
Timeframe: Measurement performed after 3 weeks of intervention/control