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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Time restricted feeding

Control

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring TRF, Hepatic glycogen, Type 2 diabetes, Insulin sensitivity

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Time Restricted Feeding

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hepatic glycogen

13C-Magnetic Resonance Spectrometry

Secondary Outcome Measures

Insulin sensitivity

Two-steps hyperinsulinaemic clamp

Full Information

NCT ID

NCT03992248

First Posted

June 18, 2019

Last Updated

February 8, 2021

Sponsor

Maastricht University

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03992248

Brief Title

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

Acronym

TRF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 31, 2019 (Actual)

Primary Completion Date

February 3, 2021 (Actual)

Study Completion Date

February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

TRF, Hepatic glycogen, Type 2 diabetes, Insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomised controlled cross-over design with two 3-week arms and a 4-week wash-out period.

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Time Restricted Feeding

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Other

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Time restricted feeding

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Eating for at least 14hrs per day.

Primary Outcome Measure Information:

Title

Hepatic glycogen

Description

13C-Magnetic Resonance Spectrometry

Time Frame

Measurement performed after 3 weeks of intervention/control

Secondary Outcome Measure Information:

Title

Insulin sensitivity

Description

Two-steps hyperinsulinaemic clamp

Time Frame

Measurement performed after 3 weeks of intervention/control

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Schrauwen, Prof. Dr.

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229ER

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

35871650

Citation

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.

Results Reference

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

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