Type 2 DiabetesTIMNCT05073068
Acute Timed Exercise and 24h Metabolism
A study testing Timing of exercise in people with Type 2 Diabetes and Overweight and Obesity, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight and Obesity
- What is being tested?
- Timing of exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Mar 2022to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Being tested
- Timing of exercise, Control
- Keywords
- Day-night rhythm, Metabolism, Metabolic flexibility, Exercise, Glycogen
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of exerciseBehavioural
An acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM
ControlBehavioural
No exercise
| Study group | Role | What they receive |
|---|---|---|
| AM exercise | Experimental | Not described Receives: Behavioral: Timing of exercise |
| PM exercise | Experimental | Not described Receives: Behavioral: Timing of exercise |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal respiratory exchange ratio
Relative carbohydrate/fat oxidation during the night
Measured: 35 hours respiration chamber stay per intervention arm
Secondary outcomes (3)
24 hour energy and substrate metabolism determined using oxygen and carbondioxide levels as measured with whole-chamber respirometry
Measured: 35 hours respiration chamber stay per intervention arm
Immune cell phenotypes determined using blood samples obtained during the interventions
Measured: 35 hours respiration chamber stay per intervention arm
Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device
Measured: 7 days post the exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start16 Mar 2022
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joris Hoeks, Dr, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073068
- Sponsor's protocol ID
- NL78628.068.21
- Acronym
- TIM
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will only discussed with other researcher on group level. We are not interested in individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes
- ClinicalTrials.gov ID
- NCT05073068
- Acronym / sponsor ID
- TIM / NL78628.068.21
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Keywords
- Day-night rhythm, Metabolism, Metabolic flexibility, Exercise, Glycogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AM exercise | Experimental | Behavioral: Timing of exercise |
| PM exercise | Experimental | Behavioral: Timing of exercise |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Healthy (determined by dependent physician)
- Man or post-menopausal woman
- Age between 50 - 75 years
- BMI ≥ 25 kg/m2
Key exclusion criteria (21 listed)
- Not meeting all inclusion criteria
- Fasting plasma glucose
- ≥ 7.0 mmol/L
- Hemoglobin < 7.8 mmol/L
- Previously diagnosed with type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of exerciseAn acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM | Behavioural | AM exercise, PM exercise |
| ControlNo exercise | Behavioural | Control |
Primary outcome
Nocturnal respiratory exchange ratio
Time frame: 35 hours respiration chamber stay per intervention arm
Relative carbohydrate/fat oxidation during the night
3 secondary outcomes
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
Immune cell phenotypes determined using blood samples obtained during the interventions
Time frame: 35 hours respiration chamber stay per intervention arm
Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device
Time frame: 7 days post the exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. Participant data will only discussed with other researcher on group level. We are not interested in individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Hoeks, Dr principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of exercise in people with Type 2 Diabetes and Overweight and Obesity, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal respiratory exchange ratio (time frame: 35 hours respiration chamber stay per intervention arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.