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Acute Timed Exercise and 24h Metabolism (TIM)

Primary Purpose

Type 2 Diabetes, Overweight and Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Timing of exercise

Control

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Day-night rhythm, Metabolism, Metabolic flexibility, Exercise, Glycogen

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Signed informed consent
Healthy (determined by dependent physician)
Man or post-menopausal woman
Age between 50 - 75 years
BMI ≥ 25 kg/m2
Pre-diabetes based on meeting at least one of the following criteria: impaired glucose tolerance defined as plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during oral glucose tolerance test in screening, impaired fasting glucose defined as fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l, insulin resistance defined as a glucose clearance rate ≤ 360 mL/kg/min as determined using OGIS120, HbA1c of 5.7-6.4%
Regular sleeping habits (7 - 9h of daily sleep)
Stable diet and weight: No weight gain or loss > 3kg in the last three months

Exclusion Criteria:

Not meeting all inclusion criteria
Fasting plasma glucose
≥ 7.0 mmol/L
Hemoglobin < 7.8 mmol/L
Previously diagnosed with type 2 diabetes
Uncontrolled hypertension
In case of an abnormal electrocardiogram at rest: this will be discussed with the responsible medical doctor
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
Any contra-indication to the Equivital telemetric pill
Hypomotility disorders of the gastro-intestinal tract
Extreme early bird or extreme night person (score ≤30 or ≥70 on morning-eveningness questionnaire self assessment)
Heavily varying sleep-wake rhythm
Night shift work during last 3 months
Travel across > 1 time zone in the last 3 months
Frequent engagement in programmed exercise as judged by the investigator
Significant food allergies/intolerance (seriously hampering study meals)
Participation in another biomedical study within 1 month before the first study visit
Using > 400mg caffeine daily (more than 4 cups of coffee or energy drinks)
Smoking
Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study
Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)

Sites / Locations

Maastricht UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

AM exercise

PM exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

Nocturnal respiratory exchange ratio

Relative carbohydrate/fat oxidation during the night

Secondary Outcome Measures

24 hour energy and substrate metabolism determined using oxygen and carbondioxide levels as measured with whole-chamber respirometry

Immune cell phenotypes determined using blood samples obtained during the interventions

Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device

Full Information

NCT ID

NCT05073068

First Posted

August 25, 2021

Last Updated

July 24, 2023

Sponsor

Maastricht University

1. Study Identification

Unique Protocol Identification Number

NCT05073068

Brief Title

Acute Timed Exercise and 24h Metabolism

Acronym

TIM

Official Title

Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University

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

The primary objective of this randomized controlled cross-over study is to investigate if an acute, glycogen lowering exercise bout performed either in the morning or late afternoon differentially affects the respiratory exchange ratio at night in men and women with prediabetes. For this purpose, participants will stay in a respiration chamber and will be subjected to either an exercise bout in the morning or late afternoon.

Detailed Description

Appropriate timing of lifestyle interventions may facilitate healthy rhythmicity in metabolism and optimize the effectiveness of such interventions in improving metabolic health. In this context, exercise is well-known to improve (skeletal muscle) energy metabolism and is an established intervention to improve muscle insulin sensitivity and to counter the development of type 2 diabetes (T2D). In addition, exercise may also have beneficial effects on the immune response that is known to impact on insulin sensitivity and overall metabolic health. In this study it is hypothesized that exercise performed at different times of the day exerts a differential effect on 24h metabolism in people at risk for developing T2D. To test this, a randomized controlled cross-over study is conducted in which participants are subjected to either an exercise in the morning or late afternoon while staying in the respiration chamber. Main outcome is substrate utilization during the night as measured with the respiration chamber, but 24-hrs blood draws will also be performed to examine effect of exercise on circulating metabolites.

6. Conditions and Keywords

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

Type 2 Diabetes, Overweight and Obesity

Keywords

Day-night rhythm, Metabolism, Metabolic flexibility, Exercise, Glycogen

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Masking Description

Participants will receive a code so that the person in charge with the data quality check and the data analyses will be blinded to the interventions.

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AM exercise

Arm Type

Experimental

Arm Title

PM exercise

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Timing of exercise

Intervention Description

An acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

No exercise

Primary Outcome Measure Information:

Title

Nocturnal respiratory exchange ratio

Description

Relative carbohydrate/fat oxidation during the night

Time Frame

35 hours respiration chamber stay per intervention arm

Secondary Outcome Measure Information:

Title

24 hour energy and substrate metabolism determined using oxygen and carbondioxide levels as measured with whole-chamber respirometry

Time Frame

35 hours respiration chamber stay per intervention arm

Title

Immune cell phenotypes determined using blood samples obtained during the interventions

Time Frame

35 hours respiration chamber stay per intervention arm

Title

Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device

Time Frame

7 days post the exercise intervention

Other Pre-specified Outcome Measures:

Title

Diurnal variation in circulating glucoregulatory hormones (e.g. insulin) analysed in blood samples obtained throughout the day

Time Frame

35 hours respiration chamber stay per intervention arm

Title

Feet sensitivity based on score on a neuropathy questionnaire

Time Frame

Baseline visit

Title

Diurnal variation in metabolite levels (e.g. glucose, free fatty acids) analysed in blood samples obtained throughout the day

Time Frame

35 hours respiration chamber stay per intervention arm

Title

Diurnal variation in core body temperature using a core temperature pill that measures 24hrs

Time Frame

35 hours respiration chamber stay per intervention arm

Title

Feet sensitivity based on a clinical foot assessment

Time Frame

Baseline visit

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 Healthy (determined by dependent physician) Man or post-menopausal woman Age between 50 - 75 years BMI ≥ 25 kg/m2 Pre-diabetes based on meeting at least one of the following criteria: impaired glucose tolerance defined as plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during oral glucose tolerance test in screening, impaired fasting glucose defined as fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l, insulin resistance defined as a glucose clearance rate ≤ 360 mL/kg/min as determined using OGIS120, HbA1c of 5.7-6.4% Regular sleeping habits (7 - 9h of daily sleep) Stable diet and weight: No weight gain or loss > 3kg in the last three months Exclusion Criteria: Not meeting all inclusion criteria Fasting plasma glucose ≥ 7.0 mmol/L Hemoglobin < 7.8 mmol/L Previously diagnosed with type 2 diabetes Uncontrolled hypertension In case of an abnormal electrocardiogram at rest: this will be discussed with the responsible medical doctor 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 Any contra-indication to the Equivital telemetric pill Hypomotility disorders of the gastro-intestinal tract Extreme early bird or extreme night person (score ≤30 or ≥70 on morning-eveningness questionnaire self assessment) Heavily varying sleep-wake rhythm Night shift work during last 3 months Travel across > 1 time zone in the last 3 months Frequent engagement in programmed exercise as judged by the investigator Significant food allergies/intolerance (seriously hampering study meals) Participation in another biomedical study within 1 month before the first study visit Using > 400mg caffeine daily (more than 4 cups of coffee or energy drinks) Smoking Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marit Kotte, MSc

Phone

43 38 85 819

Ext

+34

m.kotte@maastrichtuniversity.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte Andriessen, MSc

c.andriessen@maastrichtuniversity.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joris Hoeks, Dr

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 ER

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marit Kotte, MSc

m.kotte@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Participant data will only discussed with other researcher on group level. We are not interested in individual participant data

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Acute Timed Exercise and 24h Metabolism

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