The main objective of this study is to investigate if eating within a restricted time frame during the day (TRF) for a period of three weeks results in a decreased fasting hepatic glycogen content in the morning in adults with T2DM.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the effect of time restricted feeding on morning
(fasted) hepatic glycogen content, measured with 13C-Magnetic Resonance
Spectrometry (MRS).
Secondary outcome
The main secondary outcome is the effect of TRF on insulin sensitivity,
measured with the hyperinsulinemic 2-step clamp.
Background summary
Our society is characterised by a 24-hour culture in which people eat and are
active until late in the evening which might disturb the body's natural day and
night rhythm. It has even been shown that we eat on average 15 hours per day,
which means that we are rarely in the fasted state. Research has shown that
disrupting the day and night rhythm has adverse effects on insulin sensitivity.
In our research we will investigate whether strengthening the day and night
rhythm by means of eating during a limited period during the day (time
restricted feeding) promotes the day and night rhythm of adults with type 2
diabetes and thereby also improves the insulin sensitivity of these patients.
The underlying mechanism that we are going to study relates to the glucose
storage and utilisation of the liver. When patients are only allowed to eat
during the day, this automatically ensures that they are in the fasted state
for a longer period of time. When patients are fasted longer, the liver will
have to use glycogen to maintain glucose homeostasis and to provide the body
with energy. Our hypothesis is that the liver glycogen stores of patients with
type 2 diabetes are not fully depleted during the night and that limiting food
intake to a shorter time period during the day causes the liver glycogen
storage to be reduced and thereby improves whole body insulin sensitivity.
Study objective
The main objective of this study is to investigate if eating within a
restricted time frame during the day (TRF) for a period of three weeks results
in a decreased fasting hepatic glycogen content in the morning in adults with
T2DM.
Study design
The current study is a 3-week randomized cross-over trial, including a wash-out
period of at least 4 weeks.
Intervention
A 3-week time restricted feeding (TRF) intervention will be compared with a
3-week control arm. During TRF, subjects will only be allowed to eat within a
ten-hour time frame during the day. Subjects in the control arm will eat within
a time frame of at least 14 hours.
Study burden and risks
Results of this study will provide insight into the use of hepatic glycogen
content as a possible target for treatment of T2DM. Subjects are mostly
burdened by adjusting their eating habits for several weeks and by their time
investment. The experimental procedures are without risks, except for blood
sampling, sampling of muscle biopsies and performance of euglycemic clamp,
which can occasionally cause a local hematoma or bruising. During the clamp
there is also a (small) risk of hypoglycaemia. The risk of infection or
prolonged bleeding is low due to state of the art techniques and sterility
measures. Measurements performed during the time course of the study can
potentially lead to coincidental medical findings. Subjects will be informed
about such a finding and possibly be advised to contact their own physician
about this. Previous research has shown that the intervention (TRF) itself can
lead to improvement of insulin sensitivity. However, since this is the first
investigation looking into the effect of TRF in T2DM patients, it cannot be
simply assumed that subjects will benefit from TRF.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Well-controlled, non-insulin treated type 2 diabetes, males and postmenopausal
females, age: 50 - 75, BMI: >25 kg/m2, habitual eating times spread over a time
period of 14 hours
Exclusion criteria
Not being able to adhere to a restricted feeding schedule, use of medication
that interferes with the study outcomes as determined by the dependent
physician, extreme early bird or extreme night person, any medical condition
that will preclude the safe performance of the measurements
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67610.068.18 |