Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07075133

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 70 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Sarcopenia, Post Menopause, Type 2 Diabetes, Circadian Clock

Full registry criteria

Inclusion Criteria: * 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 * Ability to sign written informed consent before any study-specific procedure * Subject considered as reliable and capable of adhering to protocol * Subjects with Body Mass Index (BMI)≥ 30 kg/m² * Baseline eating period ≥ 14 h per day (as estimated by 95% eating interval) Exclusion Criteria: * Subjects on T2DM injectable medication or drugs able to induce hypoglycemia (glinides, sulfonylurea) * Subjects with HbA1c \> 8% * Subjects with any of the following medical conditions: * Congestive cardiac failure * Stage 4 chronic kidney disease (i.e. eGFR \< 30 ml/min/1.73 m2) * Liver cirrhosis or chronic liver disease * Any medical condition that in the opinion of the investigator could jeopardize or compromise the subject's ability to participate in the study * Subjects with previous or present history of serious eating disorder * Subjects not able to understand the informed consent form or fasting diary instructions * Subjects currently participating or has participated in another study of an investigational medication or an investigational medical device within the last 30 days * Women with menopause hormone replacement therapy

Treatments and study arms

Antidiabetic diet (control)

Other

Standard antidiabetic diet

eTRE diet

Other

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

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

Physical activity in the afternoon

Other

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

Primary outcomes

Change in skeletal muscle function4 years

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rangueil Hospital🇫🇷 Toulouse, France, France
MONTASTIER Emilie, MDContact
TOMASIK AudreyContact
MONTASTIER Emilie, MDPrincipal Investigator