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

Toulouse University Hospital

Status: Not yet enrolling

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

Treatments: Other: Antidiabetic diet (control); Other: Physical activity in the afternoon; Other: eTRE diet; Other: Physical activity in the morning

Study type: Interventional

Funder types: Other

Identifiers

NCT07075133

2025-A00832-47 (Registry Identifier)

RC31/23/0432

Details and patient eligibility

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups

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

Experimental group

Description:

Patients following a standard antidiabetic diet combined with morning exercise

Treatment:

Other: Physical activity in the morning

Other: Antidiabetic diet (control)

eTRE (chrono restriction) + exercise performed in the morning

Experimental group

Description:

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

Treatment:

Other: Physical activity in the morning

Other: eTRE diet

eTRE (chrono restriction) + exercise performed in the afternoon

Experimental group

Description:

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

Treatment:

Other: eTRE diet

Other: Physical activity in the afternoon