Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)

Metabolic Syndrome Clinical Trial

Official title:

Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271200
• Other study ID #: MG-113-GP-03
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: National Health Research Institutes, Taiwan
• Contact: Vivian Wang, Master
• Phone: +886-37-206166
• Email: ywwang[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction > 5% body weight over 24 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: January 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men or women aged from = 20 years to 65 years

• BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition

Exclusion Criteria:

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis

• Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy

• History of malignant tumors with active managements.

• Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)

• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months

• History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements.

• Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician

• Currently participating in weight loss programs or weight change in the past 3 months (>5% current body weight)

• Women who are pregnant or plan to become pregnant

• Patients who cannot be followed for 3 years (due to a health situation or migration)

• Patients who are unwilling or unable to give informed consent

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Intermittent fasting and 10,000 steps per day
Reduce calories intake and eat as "168" pattern, namely, eating foods for 8 hours while fast for 16 hours at daily basis plus walking more than 10,000 steps per day.

Locations

Country	Name	City	State
Taiwan	Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes	Zhunan	Miaoli County

Sponsors (5)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, National Taiwan University Hospital Hsin-Chu Branch, Taichung Armed Forces General Hospital, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

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Hsu CN, Hou CY, Hsu WH, Tain YL. Early-Life Origins of Metabolic Syndrome: Mechanisms and Preventive Aspects. Int J Mol Sci. 2021 Nov 2;22(21):11872. doi: 10.3390/ijms222111872. — View Citation

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Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40. — View Citation

Kalan Farmanfarma K, Kaykhaei MA, Adineh HA, Mohammadi M, Dabiri S, Ansari-Moghaddam A. Prevalence of metabolic syndrome in Iran: A meta-analysis of 69 studies. Diabetes Metab Syndr. 2019 Jan-Feb;13(1):792-799. doi: 10.1016/j.dsx.2018.11.055. Epub 2018 Dec 5. — View Citation

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Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, Kelly N, Liu YE, Philip E, Vittinghoff E, Heymsfield SB, Olgin JE, Shepherd JA, Weiss EJ. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1491-1499. doi: 10.1001/jamainternmed.2020.4153. Erratum In: JAMA Intern Med. 2020 Nov 1;180(11):1555. JAMA Intern Med. 2021 Jun 1;181(6):883. — View Citation

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Perez-Martinez P, Mikhailidis DP, Athyros VG, Bullo M, Couture P, Covas MI, de Koning L, Delgado-Lista J, Diaz-Lopez A, Drevon CA, Estruch R, Esposito K, Fito M, Garaulet M, Giugliano D, Garcia-Rios A, Katsiki N, Kolovou G, Lamarche B, Maiorino MI, Mena-Sanchez G, Munoz-Garach A, Nikolic D, Ordovas JM, Perez-Jimenez F, Rizzo M, Salas-Salvado J, Schroder H, Tinahones FJ, de la Torre R, van Ommen B, Wopereis S, Ros E, Lopez-Miranda J. Lifestyle recommendations for the prevention and management of metabolic syndrome: an international panel recommendation. Nutr Rev. 2017 May 1;75(5):307-326. doi: 10.1093/nutrit/nux014. — View Citation

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Tsao YC, Li WC, Yeh WC, Ueng SW, Chiu SY, Chen JY. The Association between Metabolic Syndrome and Related Factors among the Community-Dwelling Indigenous Population in Taiwan. Int J Environ Res Public Health. 2020 Dec 2;17(23):8958. doi: 10.3390/ijerph17238958. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks	Metabolic syndrome severity will be measured by using Z score derived from Taiwan Biobank and Metabolic syndrome severity score (MSSS): MSSS calculation will be performed with the online tool "METS Severity Calculator" at ttp://publichealth.hsc.wvu.edu/biostatistics/metabolic-syndrome-severity-calculator/mets-severity-calculator/. The equations for calculation of MSSS are based on the NHANES study in the USA with the following arguments: age, race, gender, waist circumference, triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, systolic blood pressure (SBP) and blood glucose levels.	24 weeks