Diabetes Mellitus, Type 2NCT05108987
Exercise and Time of Day in Type 2 Diabetes
A study testing Morning Exercise and Afternoon Exercise in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Rutgers, The State University of New Jersey at 3 sites in United States.
Trial summary
The overall purpose of the study is to test the effect exercise time of day in adults with type 2 diabetes or prediabetes. The overarching hypothesis is that afternoon exercise in the afternoon may promote better changes in metabolic and vascular insulin sensitivity. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Morning Exercise and Afternoon Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Sep 2021to 18 Dec 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >30 and <80 years old.
- Has a body mass index >25 and <45 kg/m2.
- Previously diagnosed with prediabetes and/or T2D.
- If not previously diagnosed, has a fasting blood glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7%
Who cannot join
- Morbidly obese patients (BMI >45 kg/m2) and lean patients (BMI <25 kg/m2)
- Evidence of type 1 diabetes and diabetics requiring insulin therapy.
- Subjects who have not been weight stable (>2 kg weight change in past 3 months)
- Subjects who have been recently active (>30 min of moderate/high intensity exercise, 3 times/week).
- Subjects who are smokers or who have quit smoking <1 years ago
- Subjects with abnormal estimated glomerular filtration rate (eGFR).
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- Hypertriglyceridemic (>400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects
- Hypertensive (>160/100 mmHg)
- Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with, alter the outcome measures, or impact subject safety.
- Pregnant (as evidenced by positive urine pregnancy test) or nursing women.
- Subjects with contraindications to participation in an exercise training program
- Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
- Known hypersensitivity to perflutren (contained in Definity)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Jersey Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, 08901
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, 08901
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, 08901
About this study
Official title: Exercise Time of Day for Cardiometabolic Health in Type 2 Diabetes
The overall purpose of the study is to test the effect exercise time of day in adults with type 2 diabetes or prediabetes. The overarching hypothesis is that afternoon exercise in the afternoon may promote better changes in metabolic and vascular insulin sensitivity. We anticipate that these changes will correlate with glycemic control and blood pressure changes.
Read the detailed description
Type 2 diabetes (T2D) is associated with a 3-fold cardiovascular disease (CVD) mortality risk compared with healthy controls, and it is estimated that 30 million adults in the United States have the disease. In recent years the American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) recommend moderate intensity (40-60% heart rate max, HRmax) aerobic exercise 3-5d/wk for the management of T2D. The statement also recognized that higher exercise intensity (>60% HRmax) predicts better blood glucose control than exercise volume. Cardiovascular health (e.g. fitness, blood pressure, etc.) also appears to respond in an exercise dose dependent manner. Despite these suggestions, many people exercising compensate by eating calories back from exercise, thereby negating weight loss. Moreover, compliance and adherence to exercise and diet medical counsel is disappointingly low.
Recent work has begun to target the best time of day to exercise in effort to improve weight loss and related health. This has evolved in part since circadian biology reveals people tend to become glucose intolerant, and develop insulin resistance and endothelial dysfunction in the evening compared with morning. As a result, it would be reasonable to hypothesize that exercise in the afternoon may be best at combating natural declines in health as well as optimizing training adaptations. However, not all studies agree that afternoon is the best time to exercise. In fact, some have demonstrated that 12 wks of aerobic plus resistance exercise improved glycemic control whether performed in the morning or afternoon in adults with T2D. Moreover, consistent morning exercise has been suggested to improve exercise adherence through possible enjoyment as well as lead to greater weight loss. Taken together, additional work is warranted to understand time of day in which exercise is performed given circadian influence may contribute to variations in favorable metabolic as well as vascular adaptation for CVD prevention/treatment. Excitingly, we have preliminary data showing that afternoon exercise induces greater weight loss, reductions in food intake as well as perceptions of appetite and increased insulin sensitivity when compared to morning exercisers. Thus, the overall purpose of this proposal is to determine whether exercise time of day differentially enhances likelihood of weight loss via appetite regulation as well as glycemic control. Our overarching hypothesis is that afternoon exercise will enhance the effectiveness of exercise to induce weight loss, improve appetite and improve glycemic regulation compared to exercise in the morning. Taken together, findings from this study will inform public health recommendations to contemporary behavioral strategies to treat T2D. The study will also provide much needed experimental evidence to time of day in which exercise is performed influences public health risk.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- Morning Exercise, Afternoon Exercise
- Keywords
- type 2 diabetes, exercise, cardiometabolic, metabolic health, behavioral, vascular health, blood flow, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning ExerciseBehavioural
Sixty minutes of supervised exercise at an intensity ~85% VO2max will be performed in the morning (between 7:00am - 11:00am) for up to 10 sessions.
Afternoon ExerciseBehavioural
Sixty minutes of supervised exercise at an intensity ~85% VO2max will be performed in the afternoon (between 4:00pm - 8:00pm) for up to 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Morning Exercise | Experimental | If participants are randomly assigned to this group, they will participate in exercise training in the morning (between 7:00am - 11:00am) at an exercise intensity ~85% VO2max. Participants will be asked to regularly engage in morning exercise while supervised for about 2 weeks. Receives: Behavioral: Morning Exercise |
| Afternoon Exercise | Active comparator | If participants are randomly assigned to this group, they will participate in exercise training in the afternoon (between 4:00pm - 8:00pm) at an exercise intensity ~85% VO2max. Participants will be asked to regularly engage in afternoon exercise while supervised for about 2 weeks. Receives: Behavioral: Afternoon Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The primary outcome is changes in body weight pre- and post-intervention
Measured: Over the course of 2 weeks.
Secondary outcomes (2)
Glucose Tolerance
We will examine the influence of Noom on the glucose area under the curve during the oral glucose tolerance test.
Measured: Over the course of 2 weeks.
Flow-mediated dilation
We will assess blood flow to better understand nutrient/glucose delivery.
Measured: Over the course of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start25 Sep 2021
- Primary completion17 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K Malin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Steven K Malin, PhD, Principal investigator, Rutgers University - New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108987
- Sponsor's protocol ID
- Pro2021001183
- Status last verified
- May 2026
- First submitted
- 26 Oct 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Time of Day for Cardiometabolic Health in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05108987
- Acronym / sponsor ID
- Pro2021001183
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Keywords
- type 2 diabetes, exercise, cardiometabolic, metabolic health, behavioral, vascular health, blood flow, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 5 Nov 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 overall purpose of the study is to test the effect exercise time of day in adults with type 2 diabetes or prediabetes. The overarching hypothesis is that afternoon exercise in the afternoon may promote better changes in metabolic and vascular insulin sensitivity. We anticipate that these changes will correlate with glycemic control and blood pressure changes.
Detailed description
Type 2 diabetes (T2D) is associated with a 3-fold cardiovascular disease (CVD) mortality risk compared with healthy controls, and it is estimated that 30 million adults in the United States have the disease. In recent years the American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) recommend moderate intensity (40-60% heart rate max, HRmax) aerobic exercise 3-5d/wk for the management of T2D. The statement also recognized that higher exercise intensity (>60% HRmax) predicts better blood glucose control than exercise volume. Cardiovascular health (e.g. fitness, blood pressure, etc.) also appears to respond in an exercise dose dependent manner. Despite these suggestions, many people exercising compensate by eating calories back from exercise, thereby negating weight loss. Moreover, compliance and adherence to exercise and diet medical counsel is disappointingly low.
Recent work has begun to target the best time of day to exercise in effort to improve weight loss and related health. This has evolved in part since circadian biology reveals people tend to become glucose intolerant, and develop insulin resistance and endothelial dysfunction in the evening compared with morning. As a result, it would be reasonable to hypothesize that exercise in the afternoon may be best at combating natural declines in health as well as optimizing training adaptations. However, not all studies agree that afternoon is the best time to exercise. In fact, some have demonstrated that 12 wks of aerobic plus resistance exercise improved glycemic control whether performed in the morning or afternoon in adults with T2D. Moreover, consistent morning exercise has been suggested to improve exercise adherence through possible enjoyment as well as lead to greater weight loss. Taken together, additional work is warranted to understand time of day in which exercise is performed given circadian influence may contribute to variations in favorable metabolic as well as vascular adaptation for CVD prevention/treatment. Excitingly, we have preliminary data showing that afternoon exercise induces greater weight loss, reductions in food intake as well as perceptions of appetite and increased insulin sensitivity when compared to morning exercisers. Thus, the overall purpose of this proposal is to determine whether exercise time of day differentially enhances likelihood of weight loss via appetite regulation as well as glycemic control. Our overarching hypothesis is that afternoon exercise will enhance the effectiveness of exercise to induce weight loss, improve appetite and improve glycemic regulation compared to exercise in the morning. Taken together, findings from this study will inform public health recommendations to contemporary behavioral strategies to treat T2D. The study will also provide much needed experimental evidence to time of day in which exercise is performed influences public health risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Exercise | Experimental | Behavioral: Morning ExerciseIf participants are randomly assigned to this group, they will participate in exercise training in the morning (between 7:00am - 11:00am) at an exercise intensity ~85% VO2max. Participants will be asked to regularly engage in morning exercise while supervised for about 2 weeks. |
| Afternoon Exercise | Active comparator | Behavioral: Afternoon ExerciseIf participants are randomly assigned to this group, they will participate in exercise training in the afternoon (between 4:00pm - 8:00pm) at an exercise intensity ~85% VO2max. Participants will be asked to regularly engage in afternoon exercise while supervised for about 2 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female >30 and <80 years old.
- Has a body mass index >25 and <45 kg/m2.
- Previously diagnosed with prediabetes and/or T2D.
- If not previously diagnosed, has a fasting blood glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7%
Key exclusion criteria (13 listed)
- Morbidly obese patients (BMI >45 kg/m2) and lean patients (BMI <25 kg/m2)
- Evidence of type 1 diabetes and diabetics requiring insulin therapy.
- Subjects who have not been weight stable (>2 kg weight change in past 3 months)
- Subjects who have been recently active (>30 min of moderate/high intensity exercise, 3 times/week).
- Subjects who are smokers or who have quit smoking <1 years ago
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 |
|---|---|---|
| Morning ExerciseSixty minutes of supervised exercise at an intensity ~85% VO2max will be performed in the morning (between 7:00am - 11:00am) for up to 10 sessions. | Behavioural | Morning Exercise |
| Afternoon ExerciseSixty minutes of supervised exercise at an intensity ~85% VO2max will be performed in the afternoon (between 4:00pm - 8:00pm) for up to 10 sessions. | Behavioural | Afternoon Exercise |
Primary outcome
Body Weight
Time frame: Over the course of 2 weeks.
The primary outcome is changes in body weight pre- and post-intervention
2 secondary outcomes
Glucose Tolerance
Time frame: Over the course of 2 weeks.
Flow-mediated dilation
Time frame: Over the course of 2 weeks.
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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Steven K Malin, PhD principal investigator
Rutgers University - New Brunswick
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Exercise and Afternoon Exercise in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Rutgers, The State University of New Jersey at 3 sites in United States.
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 4 inclusion and 13 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Body Weight (time frame: Over the course of 2 weeks.). 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 18 May 2026.