NCT07175740

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2004

Completed
21.3 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

August 29, 2025

Last Update Submit

September 8, 2025

Conditions

Type 2 DiabetesGlycemic Response

Keywords

MacronutrientsType 2 DiabetesGlycemic responseExercise

Outcome Measures

Primary Outcomes (1)

  • Glycemic response during and following intervention

    Plasma glucose and insulin levels following consumption of different meal compositions and following a 1-hour exercise session.

    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.

Study Arms (5)

Fasting

EXPERIMENTAL

Fasting before the exercise intervention

Dietary Supplement: FastingOther: Exercise session

Sucrose

EXPERIMENTAL

Sucrose enriched meal, consumed 2 hours before the exercise intervention

Dietary Supplement: Sucrose enriched mealOther: Exercise session

Fructose

EXPERIMENTAL

Fructose meal, consumed 2 hours before the exercise intervention.

Dietary Supplement: Fructose enriched mealOther: Exercise session

Aspartame

EXPERIMENTAL

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

Dietary Supplement: Aspartame enriched mealOther: Exercise session

Fat

EXPERIMENTAL

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

Dietary Supplement: Fat enriched mealOther: Exercise session

Interventions

FastingDIETARY_SUPPLEMENT

No meal

Fasting
Sucrose enriched mealDIETARY_SUPPLEMENT

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

Sucrose
Fructose enriched mealDIETARY_SUPPLEMENT

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

Fructose
Fat enriched mealDIETARY_SUPPLEMENT

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

Fat
Aspartame enriched mealDIETARY_SUPPLEMENT

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

Aspartame
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)

AspartameFastingFatFructoseSucrose

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes
  • Oral hypoglycemic agents

You may not qualify if:

  • Insulin
  • Other diabetes related medical complications or conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Single-blind randomized crossover design with 5 conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 16, 2025

Study Start

May 30, 2002

Primary Completion

May 28, 2004

Study Completion

May 28, 2004

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

CA(1)