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

February 8, 2021 updated by: Maastricht University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time Restricted Feeding
Participants 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.
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.
Other: Control
Participants 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.
Behavioral: Control
Eating for at least 14hrs per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic glycogen
Time Frame: Measurement performed after 3 weeks of intervention/control
13C-Magnetic Resonance Spectrometry
Measurement performed after 3 weeks of intervention/control

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: Measurement performed after 3 weeks of intervention/control
Two-steps hyperinsulinaemic clamp
Measurement performed after 3 weeks of intervention/control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Patrick Schrauwen, Prof. Dr., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2019

Primary Completion (Actual)

February 3, 2021

Study Completion (Actual)

February 3, 2021

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67610068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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