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Completed

NCT Number: NCT07175740

Effect of Macronutrients on Post-Exercise Glycemic Response in Males With Type 2 Diabetes

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

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Glycemic Response Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes
  • Oral hypoglycemic agents

Exclusion criteria

  • Insulin
  • Other diabetes related medical complications or conditions

Treatment and study plan

fasting

Dietary Supplement

No meal

Sucrose enriched meal

Dietary Supplement

175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g sucrose

Fructose enriched meal

Dietary Supplement

175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 22g fructose

Fat enriched meal

Dietary Supplement

175 ml of oatmeal cereal, one slice of bread, 30g of cheese, 15g fat

Aspartame enriched meal

Dietary Supplement

175 ml of oatmeal cereal, one slice of bread, 30g of cheese, aspartame (matched for taste)

Exercise Session

Other

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Paul Poirier

Other

Registry information

Official study title

Influence of the Macronutrient Content of a Standardized Pre-Exercise Meal on the Glycemic Response Following Exercise in Type 2 Diabetics

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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