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

Launched by UNIVERSITÉ DE SHERBROOKE · Nov 5, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how the timing of exercise can help improve blood sugar control in people with prediabetes. Researchers believe that exercising at different times of the day may have a significant impact on how the body processes nutrients and manages insulin sensitivity. The study will compare the effects of morning exercise versus afternoon exercise to see which is more effective in helping individuals with prediabetes improve their metabolism and overall health.

If you are between 16 and 39 years old, have a body mass index (BMI) over 25, and meet certain criteria for prediabetes, you might be eligible to participate. Participants will be guided through both short-term and longer exercise programs at different times of the day, and the team will monitor their blood sugar levels and other health markers throughout the trial. It's important for participants to be committed to the study and follow the guidelines provided. Overall, this trial aims to find out how the right timing of exercise can lead to better health outcomes for those at risk of developing type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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.
• • BMI \> 25 kg/m2
• • To be willing and able to adhere to the specifications of the protocol;
• • To have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and were willing to participate in the study.
• Exclusion Criteria:
• • overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
• • Treatment with any drug known to affect lipid or carbohydrate metabolism, except statins (to be stopped 3 weeks prior to study A), metformin or anti-hypertensive drugs (to be stopped 7 days prior to the studies);
• • presence of liver or renal disease other than uncomplicated NASH or mild isolated proteinuria; uncontrolled thyroid disorder;
• • Uncontrolled severe hypertension, systolic pressure ≥ 180 mm Hg or diastolic pressure ≥ 110 mm Hg;
• • History of ischemic heart disease, tachyarrhythmia, QT interval prolongation, risk factors for torsade de pointes (eg hypokalemia), or taking any medication known to prolong the QT interval;
• • History of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux requiring surgery, etc.);
• • Presence of a pacemaker;
• • Having undergone a PET study or CT scan in the past year;
• • Any contraindication to stopping statins for 3 months and stopping an anti-hypertensive medication and metformin for 7 days;
• • smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day;
• • No blood donation two month prior the study;
• • prior history or current fasting plasma cholesterol level \> 7 mmol/l or fasting TG \> 6 mmol/l.