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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Type 2 Diabetes; Sarcopenia; Post Menopause; Circadian Clock
• Intervention / Treatment: Other: Antidiabetic diet (control); Other: Physical activity in the morning; Other: eTRE diet; Other: Physical activity in the afternoon

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: TOMASIK Audrey; Phone Number: +33 5 61 77 85 97; Email: tomasik.a@chu-toulouse.fr
• Study Contact Backup: Name: MONTASTIER Emilie, MD; Phone Number: +33 5 61 32 30 41; Email: montastier.e@chu-toulouse.fr

Study Locations

• France
  • France
    • Toulouse, France, France, 31000
      • Rangueil Hospital
      • Contact: TOMASIK Audrey; Phone Number: +33 5 61 77 85 97; Email: tomasik.a@chu-toulouse.fr
      • Contact: MONTASTIER Emilie, MD; Phone Number: +33 5 61 32 30 41; Email: montastier.e@chu-toulouse.fr
      • Principal Investigator: MONTASTIER Emilie, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet control (no chrono restriction) + exercise performed in the morning; Patients following a standard antidiabetic diet combined with morning exercise	Other: Antidiabetic diet (control); Standard antidiabetic diet; Other: Physical activity in the morning; Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises
Experimental: eTRE (chrono restriction) + exercise performed in the morning; Patients following the eTRE program combined with physical exercise performed in the morning	Other: Physical activity in the morning; Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises; 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
Experimental: eTRE (chrono restriction) + exercise performed in the afternoon; Patients following the eTRE program combined with physical exercise performed in the afternoon	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; Other: Physical activity in the afternoon; The physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 years
• 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.	4 years
Change in HbA1c, during an oral glucose tolerance test	Change in HbA1c (in percentage), during an oral glucose tolerance test	4years
Change in fasting glucose, during an oral glucose tolerance test	Change in fasting glucose (g/l), during an oral glucose tolerance test	4years
Change in 2h blood glucose, during an oral glucose tolerance test	Change in 2h blood glucose (g/l), during an oral glucose tolerance test	4 years
Change of the insulin resistance index (HOMA-IR)	Change of the insulin resistance index (HOMA-IR) from fasting parameters: from fasting insulin levels (mU/mL) and fasting blood glucose levels (mmol/L)	4years
Change of the insulin sensitivity index (HOMAβ)	Change of the insulin sensitivity index (HOMAβ) from fasting parameters: from fasting insulinemia (mU/mL) and fasting blood glucose (mmol/L)	4years
Change in body weight (kg)		4years
Change in body mass index (kg/m2)		4years
Change in waist circumference (cm)		4years
Change in waist-to-hip ratio (without unit)		4years
Change in body composition	Change in body composition (fat mass, lean mass, bone mass, muscle mass)	4years
Change in blood pressure	Change in systolic and diastolic pressure (mmHg)	4years
Change in plasma lipid profile	Liver and muscle lipid content will be measured by MRI.	4years
Change in muscle function	Change in muscle function assessed by various tests, such as: Prehension strength: The value of the hand grip strength is measured with a dynamometer for 3 to 5 seconds by 3 measurements with each hand. The average of the 3 measurements for each hand will allow the dominant hand to be interpreted	4 years
Change in muscle function	Change in muscle function assessed by various tests, such as: SPPB score: Assesses physical performance and distinguishes between people with severe disability (0-4 points), moderate or frail (4-6 points), mild or pre-frail (7-9 points), and those without significant disability or independent (10-12 points).	4 years
Change in visceral fat (kg)		4 years
Change in liver fat (kg)		4 years
Change in muscle fat (kg)		4 years
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).	4 years
Change in muscle function	Change in muscle function assessed by various tests such as: 6 min walk test: At the 6th minute, the operator also notes the level of dyspnea.	4 years

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: MONTASTIER Emilie, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Menopause; women; Muscle Function; Metabolic Health; Timing of exercise; Timing of eating
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Sarcopenia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: RC31/23/0432; 2025-A00832-47 (Registry Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No