An interventional study of Antidiabetic diet (control) and eTRE diet in Obesity, Sarcopenia and Post Menopause, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention
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
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 45 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with any of the following medical conditions:
Patients following a standard antidiabetic diet combined with morning exercise
Other: Antidiabetic diet (control) · Other: Physical activity in the morning
Patients following the eTRE program combined with physical exercise performed in the morning
Other: eTRE diet · Other: Physical activity in the morning
Patients following the eTRE program combined with physical exercise performed in the afternoon
Other: eTRE diet · Other: Physical activity in the afternoon
Standard antidiabetic 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
Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises
The physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.
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.
Time frame: 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).
Time frame: 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.
Time frame: 4 years
Change in HbA1c, during an oral glucose tolerance test
Change in HbA1c (in percentage), during an oral glucose tolerance test
Time frame: 4years
Change in fasting glucose, during an oral glucose tolerance test
Change in fasting glucose (g/l), during an oral glucose tolerance test
Time frame: 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
Time frame: 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)
Time frame: 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)
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
Change in body composition (fat mass, lean mass, bone mass, muscle mass)
Time frame: 4years
Change in blood pressure
Change in systolic and diastolic pressure (mmHg)
Time frame: 4years
Change in plasma lipid profile
Liver and muscle lipid content will be measured by MRI.
Time frame: 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
Time frame: 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).
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
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).
Time frame: 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.
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Toulouse