Chrono-restricted Diet and Physical Activity as a New Preventive Strategy for Sarcopenia in Postmenopausal Women With Obesity and Type 2 Diabetes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Antidiabetic diet (control)

    Other intervention

    Standard antidiabetic diet

  • eTRE diet

    Other intervention

    eTRE 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 intervention

    Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises

  • Physical activity in the afternoon

    Other intervention

    The physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Diet control (no chrono restriction) + exercise performed in the morningExperimental treatment 2 interventions
Group B: eTRE (chrono restriction) + exercise performed in the morningExperimental treatment 2 interventions
Group C: eTRE (chrono restriction) + exercise performed in the afternoonExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
4 years

Secondary outcomes

1

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).

Time frame
4 years
2

• 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.

Time frame
4 years
3

Change in HbA1c, during an oral glucose tolerance test

Change in HbA1c (in percentage), during an oral glucose tolerance test

Time frame
4years
4

Change in fasting glucose, during an oral glucose tolerance test

Change in fasting glucose (g/l), during an oral glucose tolerance test

Time frame
4years

Other outcomes

Sponsors and contacts

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