Pre-diabetesTimed TrainingNCT06014684
Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes
A study testing Timing of exercise in people with Pre-diabetes and Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
n a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-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
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2023to 31 Mar 2026
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-75 years.
- Body mass index (BMI) ≥25 kg/m2
- Male, or postmenopausal (at least 1 year post cessation of menses) female
- Pre-diabetes based on one or a combination of the following criteria:
- Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
- ImpairedFastingGlucose(IFG):Fastingplasmaglucose≥6.1mmol/land≤6.9 mmol/l
- Insulin Resistance: glucose clearance rate ≤ 360 mL/kg/min, as determined during the OGTT using OGIS120.
- HbA1cof5.7-6.4%
Who cannot join
- Type 2 diabetes
- Patients with active congestive heart failure and and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Any contra-indication for MRI scanning
- Alcohol consumption of >3 servings per day for man and >2 servings per day for woman
- Smoking
Show all 14Show fewer
- Unstable body weight (weight gain or loss > 5kg in the last 3 months)
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results.
- Medication use known to hamper subject's safety during the study procedures.
- Subjects who do not want to be informed about unexpected medical findings.
- Men: Hb <8.0 mmol/L, Women: Hb <7.0 mmol/l
- Heavily varying sleep-wake rhythm (i.e. night shift work and travels across time zones).
- Significant food allergies/intolerance (seriously hampering study meals)
- Blood donation during or within 2 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
n a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear.
The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM).
Read the detailed description
Rationale: Various metabolic processes, including resting metabolic rate, insulin sensitivity and insulin secretion, follow a recurring 24-hour cycle. These rhythms are shown to be disturbed in in pre-diabetes volunteers compared to young healthy volunteers. In a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear.
Objective: The main objective of this study is to determine whether prolonged exercise training in the afternoon (15:00-17:00 PM) differs from exercise training in the morning (07:00-09:00 AM) in improving insulin sensitivity in individuals with pre-diabetes, and to investigate its underlying mechanisms.
Study design: The present study is a randomized double arm longitudinal intervention study in a pre and post design.
Study population: 24 pre-diabetic individuals (men and postmenopausal women aged 40 - 75 years and with BMI ≥ 25 and ≤ 38 kg/m2) will complete this study (12 participants in the morning training group and 12 participants in the afternoon training group). From experience with similar studies, we estimate a drop-out rate of 20% and a screening failure of 70% (because individuals often do not know they are pre-diabetic). This results in maximally 30 participants that have to be included and 100 participants that have to be screened (maximally).
Intervention (if applicable): Participants will perform a 12-weeks supervised high intensity interval training (HIIT) program with three ~30 min exercise sessions per week. Participants will be randomly assigned to the morning or afternoon training time. To assess the outcomes, participants will come to the university for a 43h measurement period both before and after the 12-week training program.
Main study parameters/endpoints: The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM). The secondary outcomes are 24h energy and substrate metabolism. Exploratory outcomes are body composition, intrahepatic lipid content and composition, hepatic insulin sensitivity, hepatic glycogen levels, maximal aerobic capacity, skeletal muscle oxidative capacity, visceral and subcutaneous adipose tissue volume, sleeping metabolic rate, blood glucose levels (continuously measured over 7days) and immune responses.
- Conditions
- Pre-diabetes, Overweight and Obesity
- Being tested
- Timing of exercise
- Medical subject headings
- Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of exerciseBehavioural
High Intensity Interval Training (HIIT) program for 12 weeks (3 per week/36 sessions in total)
| Study group | Role | What they receive |
|---|---|---|
| AM exercise | Experimental | HIIT program performed between 07:00-09:00 AM Receives: Behavioral: Timing of exercise |
| PM exercise | Experimental | HIIT program performed between 15:00-17:00 PM Receives: Behavioral: Timing of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
nocturnal glucose levels
The main objective of this study is to determine whether prolonged exercise training in the afternoon differs from exercise training in the morning in improving nocturnal glucose levels insulin sensitivity in individuals with pre-diabetes.
Measured: measured before and after the 12 weeks training program
Secondary outcomes (2)
24h whole body energy expenditure
energy expenditure as measured by a 24h stay in the respiration chamber
Measured: measured before and after the 12 weeks training program
24h substrate metabolism
24h substrate metabolism as measured by a 24h stay in the respiration chamber
Measured: measured before and after the 12 weeks training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start13 Jul 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014684
- Sponsor's protocol ID
- NL83421.068.22
- Acronym
- Timed Training
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes
- ClinicalTrials.gov ID
- NCT06014684
- Acronym / sponsor ID
- Timed Training / NL83421.068.22
- Conditions
- Pre-diabetes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Aug 2023 (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.
n a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear.
The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM).
Detailed description
Rationale: Various metabolic processes, including resting metabolic rate, insulin sensitivity and insulin secretion, follow a recurring 24-hour cycle. These rhythms are shown to be disturbed in in pre-diabetes volunteers compared to young healthy volunteers. In a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear.
Objective: The main objective of this study is to determine whether prolonged exercise training in the afternoon (15:00-17:00 PM) differs from exercise training in the morning (07:00-09:00 AM) in improving insulin sensitivity in individuals with pre-diabetes, and to investigate its underlying mechanisms.
Study design: The present study is a randomized double arm longitudinal intervention study in a pre and post design.
Study population: 24 pre-diabetic individuals (men and postmenopausal women aged 40 - 75 years and with BMI ≥ 25 and ≤ 38 kg/m2) will complete this study (12 participants in the morning training group and 12 participants in the afternoon training group). From experience with similar studies, we estimate a drop-out rate of 20% and a screening failure of 70% (because individuals often do not know they are pre-diabetic). This results in maximally 30 participants that have to be included and 100 participants that have to be screened (maximally).
Intervention (if applicable): Participants will perform a 12-weeks supervised high intensity interval training (HIIT) program with three ~30 min exercise sessions per week. Participants will be randomly assigned to the morning or afternoon training time. To assess the outcomes, participants will come to the university for a 43h measurement period both before and after the 12-week training program.
Main study parameters/endpoints: The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM). The secondary outcomes are 24h energy and substrate metabolism. Exploratory outcomes are body composition, intrahepatic lipid content and composition, hepatic insulin sensitivity, hepatic glycogen levels, maximal aerobic capacity, skeletal muscle oxidative capacity, visceral and subcutaneous adipose tissue volume, sleeping metabolic rate, blood glucose levels (continuously measured over 7days) and immune responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM exercise | Experimental | Behavioral: Timing of exerciseHIIT program performed between 07:00-09:00 AM |
| PM exercise | Experimental | Behavioral: Timing of exerciseHIIT program performed between 15:00-17:00 PM |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 40-75 years.
- Body mass index (BMI) ≥25 kg/m2
- Male, or postmenopausal (at least 1 year post cessation of menses) female
- Pre-diabetes based on one or a combination of the following criteria:
Key exclusion criteria (14 listed)
- Type 2 diabetes
- Patients with active congestive heart failure and and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Any contra-indication for MRI scanning
- Alcohol consumption of >3 servings per day for man and >2 servings per day for woman
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 exerciseHigh Intensity Interval Training (HIIT) program for 12 weeks (3 per week/36 sessions in total) | Behavioural | AM exercise, PM exercise |
Primary outcome
nocturnal glucose levels
Time frame: measured before and after the 12 weeks training program
The main objective of this study is to determine whether prolonged exercise training in the afternoon differs from exercise training in the morning in improving nocturnal glucose levels insulin sensitivity in individuals with pre-diabetes.
2 secondary outcomes
24h whole body energy expenditure
Time frame: measured before and after the 12 weeks training program
24h substrate metabolism
Time frame: measured before and after the 12 weeks training program
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 17 Apr 2026.
Related trials for Pre-diabetes
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Active, not recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pre-diabetes and Overweight and Obesity, run by Maastricht University Medical Center 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 14 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 17 Apr 2026. 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 glucose levels (time frame: measured before and after the 12 weeks training program). 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 17 Apr 2026.