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

NCT ID: NCT07175740

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-30
• Study Completion Date: 2004-05-28

Brief 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. 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.

Conditions

Type 2 Diabetes; Glycemic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Fasting

Fasting before the exercise intervention

Group Type: EXPERIMENTAL

Fasting

Intervention Type: DIETARY_SUPPLEMENT

No meal

Exercise session

Intervention Type: 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)

Sucrose

Sucrose enriched meal, consumed 2 hours before the exercise intervention

Group Type: EXPERIMENTAL

Sucrose enriched meal

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise session

Intervention Type: 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)

Fructose

Fructose meal, consumed 2 hours before the exercise intervention.

Group Type: EXPERIMENTAL

Fructose enriched meal

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise session

Intervention Type: 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)

Aspartame

Aspartame enriched meal, consumed 2 hours before the exercise intervention.

Group Type: EXPERIMENTAL

Aspartame enriched meal

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise session

Intervention Type: 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)

Fat

Fat enriched meal, consumed 2 hours before the exercise intervention.

Group Type: EXPERIMENTAL

Fat enriched meal

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise session

Intervention Type: 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)

Interventions

Fasting

No meal

Intervention Type: DIETARY_SUPPLEMENT

Sucrose enriched meal

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

Intervention Type: DIETARY_SUPPLEMENT

Fructose enriched meal

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

Intervention Type: DIETARY_SUPPLEMENT

Fat enriched meal

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

Intervention Type: DIETARY_SUPPLEMENT

Aspartame enriched meal

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

Intervention Type: DIETARY_SUPPLEMENT

Exercise session

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 2 Diabetes
• Oral hypoglycemic agents

Exclusion Criteria

• Insulin
• Other diabetes related medical complications or conditions

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Paul Poirier

OTHER

Sponsor Role: lead

Responsible Party

Paul Poirier

Cardiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

859

Identifier Type: -

Identifier Source: org_study_id