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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

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

TIMED Trial 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.Check my eligibility

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.See study design

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.

TIMED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have pre-diabetes or insulin resistance based on my blood sugar tests.

TIMED Trial 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured continuously 2-3 days before and 2-3 days after first and final exercise session, after 12-week exercise intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Adipose tissue dietary fatty acid (DFA) partitioning

Change in glucose control.

Change in lean organ (heart, liver, skeletal muscle) DFA partitioning

+1 more

Secondary outcome measures

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 more

TIMED 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

292 Previous Clinical Trials

69,393 Total Patients Enrolled

Laval UniversityOTHER

417 Previous Clinical Trials

172,224 Total Patients Enrolled

Wageningen UniversityOTHER

170 Previous Clinical Trials

43,776 Total Patients Enrolled

Media Library

High-intensity interval training Clinical Trial Eligibility Overview. Trial Name: NCT05123963 — N/A

Prediabetes Research Study Groups: Morning exercise, Afternoon exercise

Prediabetes Clinical Trial 2023: High-intensity interval training Highlights & Side Effects. Trial Name: NCT05123963 — N/A

High-intensity interval training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123963 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the criteria to be included in this research project?

"This medical trial seeks 48 subjects of pre-diabetic condition aged between 45 and 75 years old. Applicants must meet the following criteria: Fasting plasma glucose range 6.1 to 6.9 mmol/L, 2-hour post OGTT levels of 7.8 to 11.0 mmol/L, HbA1c scores from 6.0 to 6.4%, insulin sensitivity as measured by Oral Glucose Insulin Sensitivity Index < 360 ml/kg/min at Time 120 min., BMI > 25 kg/m2 . Additionally, candidates are expected to willingly adhere to study requirements outlined in a signed informed"

Answered by AI

Are the participants of this experiment limited to people under 60 years old?

"This study is enrolling participants over the age of 45 and under 75 years old."

Answered by AI

Are there still opportunities to sign up for this trial?

"According to clinicaltrials.gov, this medical investigation is currently enrolling patients who meet the inclusion criteria. The trial was first published on September 15th 2021 and was last refreshed on November 17th 2021."

Answered by AI

What is the aggregate amount of individuals involved in this experiment?

"Indeed, the data available on clinicaltrials.gov shows that this experiment is presently recruiting patients. It was first posted online on September 15th 2021 and last edited a few weeks ago on November 17th 2021, with a goal of enrolling 48 subjects from 1 centre."

Answered by AI

What is the principle objective of this research?

"This clinical trial, lasting 170 minutes prior and 30 minutes following a liquid meal at the baseline visit, 18-24 hours after an acute exercise session and >48hours after the final exercise bout (after 12 week intervention) will assess changes in adipose tissue dietary fatty acid partitioning. Assessments of postprandial plasma glucose turnover ([1-3H]-glucose), lean organ NEFA metabolism ([11C]-palmitate/PET acquisition), and postprandial plasma NEFA turnover ([7,7,8,8-2H]-palmitate) are also part of this study's secondary outcome"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors

2021. "Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123963.

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