Type 2 DiabetesNCT07175740
Effect of Macronutrients on Post-Exercise Glycemic Response in Males With Type 2 Diabetes
A study testing Fasting, Sucrose enriched meal and Fructose enriched meal in people with Type 2 Diabetes and Glycemic Response, run by Paul Poirier at 1 site in Canada.
Trial summary
The goal of this randomized crossover trial is to evaluate the impact of meal macronutrient composition on the glycemic response following exercise in males with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Type 2 Diabetes, Glycemic Response
- What is being tested?
- Fasting, Sucrose enriched meal and Fructose enriched meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2002to 28 May 2004
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes
- Oral hypoglycemic agents
Who cannot join
- Insulin
- Other diabetes related medical complications or conditions
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V4G5
About this study
Official title: Influence of the Macronutrient Content of a Standardized Pre-Exercise Meal on the Glycemic Response Following Exercise in Type 2 Diabetics
The goal of this randomized crossover trial is to evaluate the impact of meal macronutrient composition on the glycemic response following exercise in males with type 2 diabetes. The main question it aims to answer is:
- Is the consumption of a glucose enriched meal associated with a bigger reduction in plasma glucose following a 1-hour exercise session than other meals Researchers will compare different meal macronutrient composition to see how it affects the glycemic response after exercise.
Read more
Participants will
- Fast, then do a 1-hour exercise session
- Eat a glucose enriched meal, then do a 1-hour exercise session
- Eat a fructose enriched meal, then do a 1-hour exercise session
- Eat a fat enriched meal, then do a 1-hour exercise session
- Eat an aspartame enriched meal, then do a 1-hour exercise session
Read the detailed description
Meals The meals will be equivalent in terms of total calories (with the exception of the aspartame meal) and the percentage of protein will be the same in all four conditions. Only the fat and carbohydrates percentages will vary in the four meal conditions.
Exercise protocol Each subject will perform a maximal aerobic capacity (VO2peak) test on an ergocycle at the start of the protocol. Subsequently, at one-week intervals, each patient will perform an exercise session consisting of one hour of ergocycle at a capacity corresponding to 60% of each individual's VO2peak. The prescribed workload will be established based on the VO2peak test. Exercise will be monitored using heart rate, work, and oxygen consumption measured using an indirect calorimetry system. The five conditions will be randomized and performed at one-week intervals. Each exercise session will be supervised by a physician. Patients taking oral hypoglycemic agents will not take their medication on the morning of the exercise.
Blood samples Samples will be taken to measure glucose, free fatty acids, insulin, glucagon, and plasma catecholamines. In addition, an indirect calorimetry system will allow us to measure total substrate oxidation. For each blood sample period, there will be a 5-minute assessment as described above.
- Conditions
- Type 2 Diabetes, Glycemic Response
- Being tested
- Fasting, Sucrose enriched meal, Fructose enriched meal, Fat enriched meal, Aspartame enriched meal
- Keywords
- Macronutrients, Type 2 Diabetes, Glycemic response, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingDietary supplement
No meal
Sucrose enriched mealDietary supplement
175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g sucrose
Fructose enriched mealDietary supplement
175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g fructose
Fat enriched mealDietary supplement
175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 15g fat
Aspartame enriched mealDietary supplement
175 ml of oatmeal cereal, one slice of bread, 30g of cheese, aspartame (matched for taste)
Exercise sessionOther
A 60-minutes exercise session on a cycle ergometer (Corival 400, Quinton Instruments, Seattle, WA, USA) at 60% of the VO2peak (determined at a baseline visit)
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Fasting before the exercise intervention Receives: Dietary Supplement: Fasting; Other: Exercise session |
| Sucrose | Experimental | Sucrose enriched meal, consumed 2 hours before the exercise intervention Receives: Dietary Supplement: Sucrose enriched meal; Other: Exercise session |
| Fructose | Experimental | Fructose meal, consumed 2 hours before the exercise intervention. Receives: Dietary Supplement: Fructose enriched meal; Other: Exercise session |
| Aspartame | Experimental | Aspartame enriched meal, consumed 2 hours before the exercise intervention. Receives: Dietary Supplement: Aspartame enriched meal; Other: Exercise session |
| Fat | Experimental | Fat enriched meal, consumed 2 hours before the exercise intervention. Receives: Dietary Supplement: Fat enriched meal; Other: Exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response during and following intervention
Plasma glucose and insulin levels following consumption of different meal compositions and following a 1-hour exercise session.
Measured: Plasma glucose and insulin levels from blood samples taken at -15, 0, 15, 30, 45, 60, 75 and 90 minutes from the beginning of the exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 May 2002
- Primary completion28 May 2004
- Study completion28 May 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind randomized crossover design with 5 conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Poirier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Poirier, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175740
- Sponsor's protocol ID
- 859
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tremblay X, Piche ME, Brassard P, Ferland A, O'Connor S, Poirier P. Pre-exercise meal macronutrient composition and acute inflammatory response in males with type 2 diabetes mellitus. J Diabetes Complications. 2026 Sep;40(9):109367. doi: 10.1016/j.jdiacomp.2026.109367. Epub 2026 Jul 9.
PubMed 42442053
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Macronutrient Content of a Standardized Pre-Exercise Meal on the Glycemic Response Following Exercise in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT07175740
- Acronym / sponsor ID
- 859
- Conditions
- Type 2 Diabetes, Glycemic Response
- Keywords
- Macronutrients, Type 2 Diabetes, Glycemic response, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Paul PoirierUniversity, hospital or other
- Study start
- 30 May 2002 (actual)
- Primary completion
- 28 May 2004 (actual)
- Study completion
- 28 May 2004 (actual)
- First posted
- 16 Sep 2025 (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 goal of this randomized crossover trial is to evaluate the impact of meal macronutrient composition on the glycemic response following exercise in males with type 2 diabetes. The main question it aims to answer is:
- Is the consumption of a glucose enriched meal associated with a bigger reduction in plasma glucose following a 1-hour exercise session than other meals Researchers will compare different meal macronutrient composition to see how it affects the glycemic response after exercise.
Participants will
- Fast, then do a 1-hour exercise session
- Eat a glucose enriched meal, then do a 1-hour exercise session
- Eat a fructose enriched meal, then do a 1-hour exercise session
- Eat a fat enriched meal, then do a 1-hour exercise session
- Eat an aspartame enriched meal, then do a 1-hour exercise session
Detailed description
Meals The meals will be equivalent in terms of total calories (with the exception of the aspartame meal) and the percentage of protein will be the same in all four conditions. Only the fat and carbohydrates percentages will vary in the four meal conditions.
Exercise protocol Each subject will perform a maximal aerobic capacity (VO2peak) test on an ergocycle at the start of the protocol. Subsequently, at one-week intervals, each patient will perform an exercise session consisting of one hour of ergocycle at a capacity corresponding to 60% of each individual's VO2peak. The prescribed workload will be established based on the VO2peak test. Exercise will be monitored using heart rate, work, and oxygen consumption measured using an indirect calorimetry system. The five conditions will be randomized and performed at one-week intervals. Each exercise session will be supervised by a physician. Patients taking oral hypoglycemic agents will not take their medication on the morning of the exercise.
Blood samples Samples will be taken to measure glucose, free fatty acids, insulin, glucagon, and plasma catecholamines. In addition, an indirect calorimetry system will allow us to measure total substrate oxidation. For each blood sample period, there will be a 5-minute assessment as described above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Single-blind randomized crossover design with 5 conditions.
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Dietary Supplement: Fasting, Other: Exercise sessionFasting before the exercise intervention |
| Sucrose | Experimental | Dietary Supplement: Sucrose enriched meal, Other: Exercise sessionSucrose enriched meal, consumed 2 hours before the exercise intervention |
| Fructose | Experimental | Dietary Supplement: Fructose enriched meal, Other: Exercise sessionFructose meal, consumed 2 hours before the exercise intervention. |
| Aspartame | Experimental | Dietary Supplement: Aspartame enriched meal, Other: Exercise sessionAspartame enriched meal, consumed 2 hours before the exercise intervention. |
| Fat | Experimental | Dietary Supplement: Fat enriched meal, Other: Exercise sessionFat enriched meal, consumed 2 hours before the exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes
- Oral hypoglycemic agents
Key exclusion criteria (2 listed)
- Insulin
- Other diabetes related medical complications or conditions
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 |
|---|---|---|
| FastingNo meal | Dietary supplement | Fasting |
| Sucrose enriched meal175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g sucrose | Dietary supplement | Sucrose |
| Fructose enriched meal175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g fructose | Dietary supplement | Fructose |
| Fat enriched meal175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 15g fat | Dietary supplement | Fat |
| Aspartame enriched meal175 ml of oatmeal cereal, one slice of bread, 30g of cheese, aspartame (matched for taste) | Dietary supplement | Aspartame |
| Exercise sessionA 60-minutes exercise session on a cycle ergometer (Corival 400, Quinton Instruments, Seattle, WA, USA) at 60% of the VO2peak (determined at a baseline visit) | Other | Aspartame, Fasting, Fat, Fructose, Sucrose |
Primary outcome
Glycemic response during and following intervention
Time frame: Plasma glucose and insulin levels from blood samples taken at -15, 0, 15, 30, 45, 60, 75 and 90 minutes from the beginning of the exercise.
Plasma glucose and insulin levels following consumption of different meal compositions and following a 1-hour exercise session.
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 16 Sep 2025.
- Derived from this study: PubMed 42442053Tremblay X, Piche ME, Brassard P, Ferland A, O'Connor S, Poirier P. Pre-exercise meal macronutrient composition and acute inflammatory response in males with type 2 diabetes mellitus. J Diabetes Complications. 2026 Sep;40(9):109367. doi: 10.1016/j.jdiacomp.2026.109367. Epub 2026 Jul 9.
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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.
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 Fasting, Sucrose enriched meal and Fructose enriched meal in people with Type 2 Diabetes and Glycemic Response, run by Paul Poirier at 1 site in Canada.
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 2 inclusion and 2 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 16 Sep 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 Canada. 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?
Glycemic response during and following intervention (time frame: Plasma glucose and insulin levels from blood samples taken at -15, 0, 15, 30, 45, 60, 75 and 90 minutes from the beginning of the exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175740, which also lists 1 linked publication.
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 16 Sep 2025.