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

NCT07075133 | Not Yet Recruiting

• 2 other identifiers: RC31/23/04322025-A00832-47
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Timing of eating; Timing of exercise; Muscle Function; Metabolic Health; Obesity; Menopause; women

Outcome Measures

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.

  4 years

Secondary Outcomes (21)

• Change in muscle function

  4 years

• • Change in M value measured by hyperinsulinemic euglycemic clamp

  4 years

• Change in HbA1c, during an oral glucose tolerance test

  4years

• Change in fasting glucose, during an oral glucose tolerance test

  4years

• Change in 2h blood glucose, during an oral glucose tolerance test

  4 years

Study Arms (3)

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

EXPERIMENTAL

Patients following a standard antidiabetic diet combined with morning exercise

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

eTRE (chrono restriction) + exercise performed in the morning

EXPERIMENTAL

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

Other: eTRE diet; Other: Physical activity in the morning

eTRE (chrono restriction) + exercise performed in the afternoon

EXPERIMENTAL

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

Other: eTRE diet; Other: Physical activity in the afternoon

Interventions

Antidiabetic diet (control) OTHER

Standard antidiabetic diet

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

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

eTRE (chrono restriction) + exercise performed in the afternoon; eTRE (chrono restriction) + exercise performed in the morning

Physical activity in the morning OTHER

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

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

Physical activity in the afternoon OTHER

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

eTRE (chrono restriction) + exercise performed in the afternoon

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Rangueil Hospital

Toulouse, France, 31000, France

Location

MeSH Terms

Conditions

Obesity; Sarcopenia; Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• MONTASTIER Emilie, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MONTASTIER Emilie, MD

CONTACT

5 61 32 30 41; montastier.e@chu-toulouse.fr

TOMASIK Audrey

CONTACT

5 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 20, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: July 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)