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Afternoon vs Morning Exercise for Prediabetes (TIMED Trial)
N/A
Recruiting
Led By Denis P. Blondin, PhD
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-diabetes: Fasting plasma glucose: 6.1 to 6.9 mmol/L or 2-hour plasma glucose post 75g OGTT: 7.8 to 11.0 mmol/L and HbA1c: 6.0 to 6.4% or Insulin resistant: glucose clearance rate ≤ 360 ml/kg/min as determined using the Oral Glucose Insulin Sensitivity Index at Time 120 min.
Be older than 18 years old
Must not have
Prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 6 mmol/l
Overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured continuously 2-3 days before and 2-3 days after first and final exercise session, after 12-week exercise intervention.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether afternoon exercise is more effective than morning exercise in improving 24-hour blood glucose levels in men with prediabetes.
Who is the study for?
This trial is for men and women with prediabetes, defined by specific blood sugar levels or insulin resistance. Participants must have a BMI over 25, be able to follow the study protocol, and provide informed consent. Exclusions include recent scans, smoking, heavy drinking, certain medical conditions like uncontrolled thyroid disorders or heart disease, and use of medications affecting metabolism.
What is being tested?
The trial tests whether exercising at different times (morning vs late afternoon) affects blood sugar control in people with prediabetes. It aims to see if timing exercise can improve how the body uses insulin and manages dietary fats in muscles and fat tissue.
What are the potential side effects?
High-intensity interval training generally has few side effects but may include muscle soreness, fatigue after workouts, increased risk of injury if not performed correctly, and possible exacerbation of underlying health issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pre-diabetes or insulin resistance based on my blood sugar tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cholesterol or triglycerides levels have been high.
Select...
I have heart disease confirmed by my doctor and tests.
Select...
My blood pressure is not higher than 180/110 mm Hg.
Select...
I have a history of heart issues or take medication that affects my heart's rhythm.
Select...
I have had serious stomach or intestine problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured continuously 2-3 days before and 2-3 days after first and final exercise session, after 12-week exercise intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured continuously 2-3 days before and 2-3 days after first and final exercise session, after 12-week exercise intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Adipose tissue dietary fatty acid (DFA) partitioning
Change in glucose control.
Change in lean organ (heart, liver, skeletal muscle) DFA partitioning
+1 moreSecondary study objectives
Change in adipose tissue nonesterified fatty acid (NEFA) metabolism.
Change in composition and activation status of immune cell subsets
Change in dietary fatty acid oxidation
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Afternoon exerciseExperimental Treatment1 Intervention
Participant to perform high-intensity interval training in the morning (\~4 pm)
Group II: Morning exerciseActive Control1 Intervention
Participant to perform high-intensity interval training in the morning (\~9 am)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-intensity interval training
2016
Completed Phase 4
~1160
Find a Location
Who is running the clinical trial?
Université de SherbrookeLead Sponsor
304 Previous Clinical Trials
76,681 Total Patients Enrolled
Laval UniversityOTHER
432 Previous Clinical Trials
178,480 Total Patients Enrolled
Wageningen UniversityOTHER
171 Previous Clinical Trials
43,917 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cholesterol or triglycerides levels have been high.You have a pacemaker.I have heart disease confirmed by my doctor and tests.I do not have severe liver, kidney diseases, or uncontrolled thyroid issues.I have not taken drugs affecting lipid or carb metabolism, except for statins, metformin, or blood pressure meds.I can stop taking statins for 3 months and my blood pressure and diabetes medications for 7 days.My blood pressure is not higher than 180/110 mm Hg.I have a history of heart issues or take medication that affects my heart's rhythm.I have pre-diabetes or insulin resistance based on my blood sugar tests.You have had a PET scan or CT scan within the last year.You smoke more than one cigarette a day or drink more than two alcoholic beverages a day.I have had serious stomach or intestine problems.You weigh more than what is considered healthy for your height.
Research Study Groups:
This trial has the following groups:- Group 1: Morning exercise
- Group 2: Afternoon exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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