Intensive Lifestyle Intervention for Remission of Metabolic Syndrome (LIMS)
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|ClinicalTrials.gov Identifier: NCT04116905|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Intensive Lifestyle Intervention Behavioral: Conventional Treatment||Not Applicable|
Metabolic syndrome is a worldwide problem to public health, with a prevalence rate of 10-84% according to previous studies. It is associated with a series of chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver, polycystic ovary syndrome, cancer, and etc. Worth noting, obesity contributed a lot to the occurrence of metabolic syndrome, and many studies had proven the positive significance of sufficient weight loss to the improvement of components of metabolic syndrome.
The study is examining the effect of an intensive lifestyle intervention program, designed to achieve and maintain a 15% decrease in body weight by intensive calorie restriction and physical exercise, in overweight and obese volunteers with metabolic syndrome. In this program, volunteers will be supposed on very low calorie diet with partial diet replacement, followed by carefully managed food reintroduction and then weight loss maintenance. In addtion, mobile phone applications (apps) will be used during the weight loss program.
The control group will be involved in a control condition involving a program of metabolic support and education, designed to achieve and maintain a 5% decrease in body weight. Mobile phone applications (apps) will be alos adopted during the weight loss program.
The study will also test the effect of intensive lifestyle intervention on appetite, body fat, abdominal fat, gut microbiota, bone mineral density, vascular endothelial function, and etc.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Lifestyle Intervention for Remission of Metabolic Syndrome in Overweight or Obese Han Chinese Population|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||May 30, 2022|
Experimental: Intensive Lifestyle Intervention
Participants in the intensive lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain a 15% weight loss.
Behavioral: Intensive Lifestyle Intervention
The lifestyle intervention is implemented with individual supervision sessions and is aimed at achieving and maintaining at least a 15% decrease in weight from baseline. It is implemented during a 12-month period with the most intensive application during the first 4 months. To help participants achieve and maintain weight loss, partial diet replacement with very low calorie diet, strengthend exercise strategies. Mobile phone applications (apps) will be used to manage metabolic syndrome during weight loss program. Optional medications on metabolic syndrome will be utilized based on a preset algorithm and participant progress.
Active Comparator: Conventional Treatment
The conventional treatment arm provides group sessions on metabolic syndrome management and social support, aimed at a 5% weight loss.
Behavioral: Conventional Treatment
Participants assigned to conventional treatment and education are offered metabolic syndrome management and social support every 1 month, aimed at achieving and maintaining a 5% decrease in weight in 1 year. Mobile phone applications (apps) will also be used in the weight loss program.
- The remission rate of metabolic syndrome [ Time Frame: 12 months ]Participants who no longer meet the diagnostic criteria of metabolic syndrome. meet 2 or less of the following 5 criteria: Waist circumference ≥85 cm (male) or 80 cm (female); TG ≥150 mg/dL or with lipid-lowering treatment; HDL<40 mg/dL (male) /50 mg/dL (female)；SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6 mmol/L and / or with diagnosed type 2 diabetes and anti-hyperglycemic treatment.
- The proportion of participants with wight loss exceeding 15% [ Time Frame: 12 months ]The proportion of participants maintaining a weight loss of more than 15%.
- Remission of hypertension [ Time Frame: 12 months ]The proportion with BP<130/85mmHg or BP<140/90mmHg without medication.
- Remission of hyperglycemia [ Time Frame: 12 months ]The proportion with fasting blood glucose <5.6 mmol/L without medication.
- Remission of hypertriglyceridemia [ Time Frame: 12 months ]The proportion with blood triglyceride<150 mg/dl without medication.
- Remission of low HDL-C [ Time Frame: 12 months ]The proportion with HDL-C≥40 mg/dl in male or ≥50 mg/dl in female without medication.
- Remission of central obesity [ Time Frame: 12 months ]The proportion with waist circumference <85 cm in male or <80 cm in female.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116905
|Contact: Pengfei Shan, MD, PhDemail@example.com|
|Contact: Yuezhong Ren, MD||+86-057187783777|
|The Second Affiliated Hospital of Zhejiang University School of Medicine||Recruiting|
|Hangzhou, Zhejiang, China, 310009|
|Contact: Pengfei Shan, MD, PhD 86-057187783777 firstname.lastname@example.org|
|Principal Investigator:||Pengfei Shan, MD, PhD||Second Affiliated Hospital, School of Medicine, Zhejiang University|
|Principal Investigator:||Yuezhong Ren, MD||Second Affiliated Hospital, School of Medicine, Zhejiang University|