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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether changing the timing of eating and exercise can help prevent muscle loss (called sarcopenia) in postmenopausal women who have obesity and type 2 diabetes. Specifically, the study will compare how well early time-restricted eating (eating only during a shorter window earlier in the day) combined with exercising in the afternoon works, versus the same eating plan combined with morning exercise. The main goal is to see which approach improves muscle strength the most, and the study will also look at how these habits affect blood sugar control.

Women who might be eligible for this study are those between 45 and 70 years old who have gone through menopause (no periods for at least a year), have type 2 diabetes for more than one year, and have a body mass index (BMI) of 30 or higher, meaning they are classified as obese. Participants should currently manage their diabetes with lifestyle changes and certain oral medications, but not insulin or medications that can cause low blood sugar. If selected, participants will be asked to follow specific eating and exercise schedules and keep track of their meals and activity. This study is not yet recruiting, but it could offer helpful information on how timing meals and exercise might protect muscle health and improve diabetes management in this group of women.

Gender

ALL

Eligibility criteria

• 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