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New treatment option for Prediabetic State
Official title Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors
ClinicalTrials.gov ID: NCT05123963
What this study is testing
- What it's testing
- Exercise is well-known to improve skeletal muscle energy metabolism and is an established intervention to improve muscle insulin sensitivity and to counter the development of type 2 diabetes (T2D). However, given the 24h rhythmicity in substrate metabolism previously observed in healthy, lean men and the lack of such rhythmicity in men with insulin-resistance, the investigator hypothesize that appropriate timing of exercise training can maximize the metabolic health effects of exercise.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- History of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux requiring surgery, etc.);
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.