ObesityTIMEDIABNCT07075133
Chrono-restricted Diet and Physical Activity as a New Preventive Strategy for Sarcopenia in Postmenopausal Women With Obesity and Type 2 Diabetes
A study testing eTRE diet, Physical activity in the morning and Physical activity in the afternoon in people with Obesity and Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenia, Post Menopause
- What is being tested?
- eTRE diet, Physical activity in the morning and Physical activity in the afternoon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Rangueil Hospital
Toulouse, France, 31000
MONTASTIER Emilie, MD, 5 61 32 30 41 ext. +33, montastier.e@chu-toulouse.fr
TOMASIK Audrey, 5 61 77 85 97 ext. +33, tomasik.a@chu-toulouse.fr
About this study
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
Read the 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
- Being tested
- Antidiabetic diet (control), eTRE diet, Physical activity in the morning, Physical activity in the afternoon
- Keywords
- Timing of eating, Timing of exercise, Muscle Function, Metabolic Health, Obesity, Menopause, women
- Medical subject headings
- Obesity, Sarcopenia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antidiabetic diet (control)Other
Standard antidiabetic diet
eTRE dietOther
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 morningOther
Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises
Physical activity in the afternoonOther
The physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Diet control (no chrono restriction) + exercise performed in the morning | Experimental | Patients following a standard antidiabetic diet combined with morning exercise Receives: 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 Receives: 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 Receives: Other: eTRE diet; Other: Physical activity in the afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (21)
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).
Measured: 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.
Measured: 4 years
Change in HbA1c, during an oral glucose tolerance test
Change in HbA1c (in percentage), during an oral glucose tolerance test
Measured: 4years
Change in fasting glucose, during an oral glucose tolerance test
Change in fasting glucose (g/l), during an oral glucose tolerance test
Measured: 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
Measured: 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)
Measured: 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)
Measured: 4years
Change in body weight (kg)
Measured: 4years
Change in body mass index (kg/m2)
Measured: 4years
Change in waist circumference (cm)
Measured: 4years
Change in waist-to-hip ratio (without unit)
Measured: 4years
Change in body composition
Change in body composition (fat mass, lean mass, bone mass, muscle mass)
Measured: 4years
Change in blood pressure
Change in systolic and diastolic pressure (mmHg)
Measured: 4years
Change in plasma lipid profile
Liver and muscle lipid content will be measured by MRI.
Measured: 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
Measured: 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).
Measured: 4 years
Change in visceral fat (kg)
Measured: 4 years
Change in liver fat (kg)
Measured: 4 years
Change in muscle fat (kg)
Measured: 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).
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MONTASTIER Emilie, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075133
- Sponsor's protocol ID
- RC31/23/0432
- Other IDs
- 2025-A00832-47
- Acronym
- TIMEDIAB
- Status last verified
- May 2026
- First submitted
- 24 Jun 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chrono-restricted Diet and Physical Activity as a New Preventive Strategy for Sarcopenia in Postmenopausal Women With Obesity and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07075133
- Acronym / sponsor ID
- TIMEDIAB / RC31/23/0432
- Conditions
- Obesity, Sarcopenia, Post Menopause, Type 2 Diabetes, Circadian Clock
- Keywords
- Timing of eating, Timing of exercise, Muscle Function, Metabolic Health, Obesity, Menopause, women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet control (no chrono restriction) + exercise performed in the morning | Experimental | Other: Antidiabetic diet (control), Other: Physical activity in the morningPatients following a standard antidiabetic diet combined with morning exercise |
| eTRE (chrono restriction) + exercise performed in the morning | Experimental | Other: eTRE diet, Other: Physical activity in the morningPatients following the eTRE program combined with physical exercise performed in the morning |
| eTRE (chrono restriction) + exercise performed in the afternoon | Experimental | Other: eTRE diet, Other: Physical activity in the afternoonPatients following the eTRE program combined with physical exercise performed in the afternoon |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- Subjects with previous or present history of serious eating disorder
- Subjects not able to understand the informed consent form or fasting diary instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidiabetic diet (control)Standard antidiabetic diet | Other | Diet control (no chrono restriction) + exercise performed in the morning |
| eTRE dieteTRE 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 | eTRE (chrono restriction) + exercise performed in the afternoon, eTRE (chrono restriction) + exercise performed in the morning |
| Physical activity in the morningPhysical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises | Other | Diet control (no chrono restriction) + exercise performed in the morning, eTRE (chrono restriction) + exercise performed in the morning |
| Physical activity in the afternoonThe physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises. | Other | eTRE (chrono restriction) + exercise performed in the afternoon |
Primary outcome
Change in skeletal muscle function
Time frame: 4 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.
21 secondary outcomes
Change in muscle function
Time frame: 4 years
• Change in M value measured by hyperinsulinemic euglycemic clamp
Time frame: 4 years
Change in HbA1c, during an oral glucose tolerance test
Time frame: 4years
Change in fasting glucose, during an oral glucose tolerance test
Time frame: 4years
Change in 2h blood glucose, during an oral glucose tolerance test
Time frame: 4 years
Change of the insulin resistance index (HOMA-IR)
Time frame: 4years
Change of the insulin sensitivity index (HOMAβ)
Time frame: 4years
Change in body weight (kg)
Time frame: 4years
Change in body mass index (kg/m2)
Time frame: 4years
Change in waist circumference (cm)
Time frame: 4years
Change in waist-to-hip ratio (without unit)
Time frame: 4years
Change in body composition
Time frame: 4years
Change in blood pressure
Time frame: 4years
Change in plasma lipid profile
Time frame: 4years
Change in muscle function
Time frame: 4 years
Change in muscle function
Time frame: 4 years
Change in visceral fat (kg)
Time frame: 4 years
Change in liver fat (kg)
Time frame: 4 years
Change in muscle fat (kg)
Time frame: 4 years
Change in muscle function
Time frame: 4 years
Change in muscle function
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MONTASTIER Emilie, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eTRE diet, Physical activity in the morning and Physical activity in the afternoon in people with Obesity and Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MONTASTIER Emilie, MD (5 61 32 30 41 ext. +33, montastier.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skeletal muscle function (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.