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

NCT ID: NCT07075133

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2029-07-15

Brief Summary

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

Detailed Description

Overweight, obesity, aging and menopause are all independent risk factors in the development of type 2 diabetes mellitus (T2DM). Older women with T2DM are at especially high risk for sarcopenia, i.e. loss of skeletal muscle mass and force, and cardiovascular diseases. The first line of T2DM treatment is based on lifestyle changes including weight loss and physical activity. One major current medical challenge is to find novel lifestyle therapies able to reduce cardiometabolic risk while perserving muscle mass in obese older individuals. As a result, intermittent fasting approaches, including time-restricted feeding/eating (TRF/TRE), have been offered as alternative dietary strategies that may have beneficial effects on weight control and T2DM. It has been recently observed that long-term TRF improve glucose homeostasis while perserving muscle mass and force in female obese mice. The purpose of TIMEDIAB is to demonstrate that early TRE (eTRE) combined to late (afternoon) exercise will outperform eTRE combined to morning exercise on various components of muscle health as primary endpoint, and blood glucose control, body composition, energy balance, cardiovascular risk, and metabolic health as secondary endpoints. This study will pave the way to larger scale randomized clinical trials investigating the long-term effects/benefits of such intervention and in other target populations.

Conditions

Obesity; Sarcopenia; Post Menopause; Type 2 Diabetes; Circadian Clock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diet control (no chrono restriction) + exercise performed in the morning

Patients following a standard antidiabetic diet combined with morning exercise

Group Type: EXPERIMENTAL

Antidiabetic diet (control)

Intervention Type: OTHER

Standard antidiabetic diet

Physical activity in the morning

Intervention Type: OTHER

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

eTRE (chrono restriction) + exercise performed in the morning

Patients following the eTRE program combined with physical exercise performed in the morning

Group Type: EXPERIMENTAL

eTRE diet

Intervention Type: 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

Intervention Type: OTHER

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

eTRE (chrono restriction) + exercise performed in the afternoon

Patients following the eTRE program combined with physical exercise performed in the afternoon

Group Type: EXPERIMENTAL

eTRE diet

Intervention Type: 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 afternoon

Intervention Type: OTHER

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

Interventions

Antidiabetic diet (control)

Standard antidiabetic diet

Intervention Type: OTHER

eTRE diet

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

Intervention Type: OTHER

Physical activity in the morning

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

Intervention Type: OTHER

Physical activity in the afternoon

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MONTASTIER Emilie, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Rangueil Hospital

Toulouse, France, France

Countries

France

Central Contacts

MONTASTIER Emilie, MD

Role: CONTACT

montastier.e@chu-toulouse.fr

5 61 32 30 41 ext. +33

TOMASIK Audrey

Role: CONTACT

tomasik.a@chu-toulouse.fr

5 61 77 85 97 ext. +33

Facility Contacts

MONTASTIER Emilie, MD

Role: primary

montastier.e@chu-toulouse.fr

5 61 32 30 41 ext. +33

TOMASIK Audrey

Role: backup

tomasik.a@chu-toulouse.fr

5 61 77 85 97 ext. +33

Other Identifiers

2025-A00832-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

RC31/23/0432

Identifier Type: -

Identifier Source: org_study_id