Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.

Type 2 Diabetes Mellitus Clinical Trial

— TRF  

Official title:

Effect of Time Restricted Feeding on Hepatic Glycogen Depletion and Insulin Sensitivity in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992248
• Other study ID #: NL67610068
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: February 3, 2021

Study information

• Verified date: February 2021
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Time restricted feeding
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.
• Control
Eating for at least 14hrs per day.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic glycogen	13C-Magnetic Resonance Spectrometry	Measurement performed after 3 weeks of intervention/control
Secondary	Insulin sensitivity	Two-steps hyperinsulinaemic clamp	Measurement performed after 3 weeks of intervention/control