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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Antidiabetic diet (control)
  Standard antidiabetic diet
• Другое 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
• Другое Physical activity in the morning
  Physical exercise will consist of 3 weekly morning sessions that will combine aerobic and resistance exercises
• Другое Physical activity in the afternoon
  The physical exercise will consist of 3 weekly afternoon sessions that will combine aerobic and resistance exercises.

Первичные конечные точки

• Change in skeletal muscle function [Срок оценки: 4 years]

Вторичные конечные точки (12)

• Change in muscle function [Срок оценки: 4 years]
• • Change in M value measured by hyperinsulinemic euglycemic clamp [Срок оценки: 4 years]
• Change in HbA1c, during an oral glucose tolerance test [Срок оценки: 4years]
• Change in fasting glucose, during an oral glucose tolerance test [Срок оценки: 4years]
• Change in 2h blood glucose, during an oral glucose tolerance test [Срок оценки: 4 years]
• Change of the insulin resistance index (HOMA-IR) [Срок оценки: 4years]
• Change of the insulin sensitivity index (HOMAβ) [Срок оценки: 4years]
• Change in body weight (kg) [Срок оценки: 4years]
• Change in body mass index (kg/m2) [Срок оценки: 4years]
• Change in waist circumference (cm) [Срок оценки: 4years]
• Change in waist-to-hip ratio (without unit) [Срок оценки: 4years]
• Change in body composition [Срок оценки: 4years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Rangueil Hospital — Toulouse

Идентификаторы

NCT: NCT07075133 · RC31/23/0432 · 2025-A00832-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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