About this trial
The aim of TIMEDIAB is to demonstrate that early TRE (eTRE) combined to late (afternoon) exercise will outperform eTRE combined to morning exercise on muscle function as primary endpoint, and glucose homeostasis as secondary endpoint
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Post-menopausal women (amenorrhea for at least 12 months, confirmed by gonadotrophins measures)
Age range 45-70 years
T2DM diagnosed for more than 1 year
Subjects with T2DM treated with lifestyle control alone or associated with metformine ± DPP4 inhibitors
Disqualifiers
Subjects on T2DM injectable medication or drugs able to induce hypoglycemia (glinides, sulfonylurea)
Subjects with HbA1c > 8%
Congestive cardiac failure
Stage 4 chronic kidney disease (i.e. eGFR < 30 ml/min/1.73 m2)
Trial design
Parallel
Treatments tested in this trial
Antidiabetic diet (control)
Other interventionStandard antidiabetic diet
eTRE diet
Other interventioneTRE for a total duration of 12 weeks. During the eTRE, volunteers will have to eat and drink (meals + snacks, medication) exclusively during an 8-hour period which will extend between 6 a.m. (flexible: or 7 a.m. or 8 a.m.) in the morning and 2 p.m. (depending on the chosen start time: or 3 p.m. or 4 p.m.), which corresponds to a fasting period of 16 hours per day
Physical activity in the morning
Other interventionPhysical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises
Physical activity in the afternoon
Other interventionThe physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.
Treatment groups
Trial outcomes
Primary outcomes
Change in skeletal muscle function
Change in skeletal muscle function, assessed by 30-CTS score at inclusion (baseline) and 12 weeks after diet/exercise program; This test is used to assess lower limb strength. The score corresponds to the total number of standing positions correctly performed within the allotted 30 seconds.
Secondary outcomes
Change in muscle function
Change in muscle function assessed by various tests, such as: \- TUG Score ( calculates the time it takes to get up from a chair without using your arms. A time \<10 seconds is normal; 10\>time\<20 is a marker of frailty; time \<20 seconds:the elderly person is at high risk of falling).
• Change in M value measured by hyperinsulinemic euglycemic clamp
Systemic insulin sensitivity will be assessed using a euglycemic hyperinsulinemic clamp, oral hyperglycemia, and insulin signaling pathway studies. The M value (unitless measurement) determined during the clamp will be the marker of systemic insulin sensitivity.
Change in HbA1c, during an oral glucose tolerance test
Change in HbA1c (in percentage), during an oral glucose tolerance test
Change in fasting glucose, during an oral glucose tolerance test
Change in fasting glucose (g/l), during an oral glucose tolerance test
Sponsors and contacts
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