Lifestyle Intervention Trial in High Metabolic Risk Chinese

Obesity Clinical Trial

Official title:

Lifestyle Intervention Trial in High Metabolic Risk Chinese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714723
• Other study ID #: CAS-LIT-202101
• Status: Completed
• Phase: N/A
• Start date: December 27, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this single-blind, randomized trial, 395 eligible volunteers, who have higher metabolic syndrome (MetS) risk and aged 20-65 years, will be assigned to one of two smartphone-based lifestyle intervention arms: 1) Programmed-smartphone intervention or 2) Programmed-smartphone plus dietitian intervention. Before and after 6-month intervention, "PhenFlex test" (PFT) was performed to examine and quantify improved metabolic flexibility.

This intervention trial will be conducted by researchers in Shanghai Institute of Nutrition and Health of the Chinese Academy of Sciences (CAS) collaborating with Zhejiang University affiliated Sir Run Run Shaw Hospital. The study protocol was approved by the Ethics Committees in Shanghai Institutes of Nutrition and Health, and in Sir Run Run Shaw Hospital.

The main aims of this study are to determine 1) efficacy of lifestyle interventions with different intensity in reducing MetS and its risk factors; 2) improved metabolic responses or flexibility defined by PFT-based homeostasis index; and 3) major genetic and nongenetic determinants for the efficacy of interventions among high MetS risk Chinese.

Description:

Metabolic syndrome, a cluster of multiple metabolic disturbances, including central obesity, dyslipidemia, hypertension, and hyperglycemia, is associated with 2-5-fold heightened risks of CVD and T2D. Compelling evidence showed that lifestyle intervention is one of effective approaches for preventing and controlling cardiometabolic diseases. However, there were considerably variations among different interventions and different persons. With widely available smartphone and APP-connected wearable devises, it is possible to provide programmed nutrition and lifestyle education to help participants achieve intervention targets, and closely monitor compliance. However, few studies investigated the efficacy of lifestyle interventions with programmed smartphone and APP-connected wearable devises in MetS management. Moreover, since present disease-based diagnoses and biomarkers may not adequately define health status, the concept of "re-redefining health" has attracted growing attention. The phenotypic flexibility and "PhenFlex test" are one of approaches to measure individuals' adaptive capacity to maintain hemostatic condition after having a standardized challenge drinker. To date, the PFT has been studied among 10,000 subjects in western countries and few studies, if any, have conducted in Chinese who have different genetic background and dietary patterns. It remains to be established whether and to what extent that the PFT-based hemostatic index system can precisely evaluate the metabolic health in Chinese.

In the current trial, 395 subjects with MetS risks were randomly assigned to either smartphone-based lifestyle intervention arms: 1) Programmed-smartphone intervention; or 2) Programmed-smartphone plus dietitian intervention. The intervention duration will be 6-month and then have 2-year follow-up. During starting and end of 6-month intervention, we included PFT during the physical examination hold in the Sir Run Run Shaw Hospital. All the subjects were given a standardized challenge drinker (75g glucose, 60 fat and 20g protein). Fasting and multiple postprandial time points samples (blood, t=0,1,3h) and urine and feces were collected to measure clinical and omics markers like metabolomics, gut microbiota and SNPs. Finally, the homeostasis index will be built to estimate improvement of individual metabolic health after the intervention. In conclusion, this study will provide scientific evidence and novel insights about the effectiveness of new intervention strategies and precise diagnostic and assessment system for cardiometabolic management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

Volunteers at high metabolic risk aged 20-65 who didn't participate in other studies in 3 months before the current research, having a certain level of education and normal cognitive ability, taking good care of himself/herself. MetS risk factors were identified by the definition proposed by the International Diabetes Federation criteria for Chinese adults. Participants should have central obesity (waist circumference =90 cm in men or =80 cm in women).

Exclusion Criteria:

• Fasting glucose>7.0mmol/L after taking insulin or other blood glucose-lowering drugs

• Diagnosed phase three hypertension or can't lowering SBP under 160mmHg after anti-hypertension drugs

• Fasting blood TG= 5.7 mmol/L or fasting LDL-C= 4.9 mmol/L after taking lipid-lowering drugs

• Pregnancy or lactation

• Obvious drug changing in three months before research

• History of drug or alcohol abuse or other substance abuse (Alcohol abuse is defined as more than 40 g/day of alcohol for woman, and more than 80g/day for man)

• Severe kidney and liver diseases (blood biomarkers such as alt, serum creatinine is 1.5 times over the scope of normal setting)

• Severe Gastrointestinal diseases (such as severe diarrhea, constipation, severe digestive tract inflammation, active peptic ulcer, acute cholecystitis, etc.)

• Having surgeries within one year before research such as heart stents implanted surgery (expect for appendicitis or hernia operation)

• Severe cardiovascular disease (e.g., heart failure, myocardial infarction, cerebral infarction, and acute myocarditis, severe arrhythmia, received the intervention therapy, etc.)

• Cancer or receiving radiotherapy and chemotherapy within 5 years

• Severe pituitary or thyroid diseases

• Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases

• Mental disorders or current use of antidepressants

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

Behavioral:
• Programmed smartphone intervention
Interactive programmed lifestyle education based on smartphone for six month
• Programmed smartphone plus dietitian intervention
Interactive programmed lifestyle education based on smartphone plus dietitians support for six month

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital;Hangzhou Dianzi University;China Jiliang University; Zhejiang Sci-Tech University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	E-selectin concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	P-selectin concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Vascular cell adhesion molecule-1(VCAM-1) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Intercellular adhesion molecule-1 (ICAM-1) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Amyloid A1(SAA1) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Tumor Necrosis Factor-a (TNF-a) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Interleukin-10(IL-10) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Interleukin-1b(IL-1b) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	C-reactive protein(CRP) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Retinol binding protein(RBP4) concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Adiponectin concentration	Concentration at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Metabolomics including profiling of free fatty acids and other metabolites	Metabolomics will be measured by LC-MS	Baseline and month 6
Other	Single nucleotide polymorphism (SNPs)	Mutations at specific sites will be detected by gene chip	Baseline
Other	Gut microbiota 16S rDNA sequencing	Gut microbiota 16S rDNA will be sequenced	Baseline and month 6
Other	HbA1c	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Insulin	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Glucagon	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Glucagon-like peptide-1	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Aspartate transaminase	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Gastric inhibitory peptide	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Alanine aminotransferase	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Serum creatinine	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	?-glutamyl transpeptidase	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Urine creatinine	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Urea nitrogen	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Other	Uric acid	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Primary	Weight	Weight will be assessed by Seca-255 (ScalesGalore) during each visit ,weight will also be assessed by Bluetooth scale at home	Baseline and month 6
Secondary	Body mass index (BMI)	Body mass index (BMI) will be assessed by Seca-201(ScalesGalore) during each visit	Baseline and month 6
Secondary	Waist circumference	Waist circumference will be assessed by Seca-201(ScalesGalore) during each visit	Baseline and month 6
Secondary	Blood pressure	Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron J750)during each visit and at home	Baseline and month 6
Secondary	Triglyceride	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Secondary	Total cholesterol	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Secondary	LDL-C	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Secondary	HDL-C	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Secondary	Glucose	Values at fasting and postprandial 60min and 3hours will be measured	Baseline and month 6
Secondary	Metabolic Homeostasis Score	A metabolic homeostasis score is a composite score that includes aggregated changes in blood biomarkers (metabolites or biomarkers or index involved in carbohydrates metabolism such as glucose, C-peptide, Matsuda index etc.; metabolites or biomarkers involved in lipid metabolism such as high-density lipoprotein cholesterol, total cholesterol, triglyceride etc.; metabolites or biomarkers involved in protein/vitamin metabolism such as creatinine; inflammatory or cytokines such as interleukin-6 etc.; hormones; anthropometric measures etc.).; The metabolic homeostasis score is a composite score, that is calculated by the average of the scores of above-mentioned features using a certain computational algorithm. The larger the metabolic homeostasis score is, the worse the homeostatic resilience of the person, and vice versa.	Baseline and month 6
Secondary	Body composition	Body composition will be assessed by InBody-720 multi-frequency bioelectrical impedance device.	Baseline and month 6
Secondary	Compliance	Behavioral compliance will be assessed by wearable devices and bluetooth devices.	Whole 6-month intervention