Study of Metabolic Homeostasis in Chinese

NCT04173728 | Completed DMC

• 1 other identifier: CAS-MH-201911
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

In this open-label, acute intervention study, we will recruit 120 sex-matched participants aged 20-70 years (100 normal or overweight/obese subjects and 20 Mets subjects). They will be assigned to one of the six groups according to age, BMI and with and without MetS and have a standardized mixed macronutrient tolerance test (MMTT) by orally administered a 400-ml beverage (75g glucose, 60g lipid, and 20g protein). Fasting and postprandial blood, and urine and fecal samples will be collected. The primary aim is to establish a more comprehensive system to quantify different aspects of metabolic health based on fasting and postprandial data. The study protocol has been approved by the Ethics Committee of Shanghai Institutes for Biological Sciences.

Conditions

Healthy; Metabolic Syndrome

Keywords

Metabolic health; MMTT; Resilience

Outcome Measures

Primary Outcomes (1)

• Health state map (HSM)

  A two-dimensional system comprising "Health Phenotype Score" for fasting features and "Homeostatic Resilience Score" for post-MMTT features will be built. We want to investigate whether HSM is more informative than a one-dimensional model with fasting data and the Mixed-score model combining fasting and postprandial data. Features includes BMI, blood pressure, HbA1c, body compositions, glucose, insulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triacylglycerol, alanine aminotransferase, aspartate aminotransferase, gamma- glutamyl transpeptidase, C-reactive protein, free triiodothyronine, free thyroxine, thyroid stimulating hormone, gastric inhibitory polypeptide, glucagon-like peptide-1, adiponectin, leptin, intercellular cell adhesion molecule-1, vascular cell adhesion molecule-1, inflammatory factors (such as interleukin, -6, -8 and 1b, and tumor Necrosis Factor-α), and targeted metabolites (such as amino acids, acylcarnitines).

  fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)

Study Arms (1)

Standardized mixed macronutrients tolerance test

OTHER

Subjects with different age and BMI will be included. 1) 20 subjects aged 20-29 years with normal body weight (18.5 ≤BMI\<24kg/m2); 2) 40 20 subjects aged 30-70 49 years with normal body weight (18.5 ≤ BMI\<24kg/m2); 3) 40 20 subjects aged 30-70 49 years with overweight or obesity (BMI\<24kg/m2).); 4) 20 subjects aged 50-70 years with normal body weight (18.5 ≤ BMI\<24kg/m2); 5) 20 subjects aged 30-49 years with overweight or obesity (BMI\<24kg/m2); 6) 20 subjects aged 30-70 years with MetS.

Other: Standard mixed macronutrients tolerance test

Interventions

Standard mixed macronutrients tolerance test OTHER

Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein.

Standardized mixed macronutrients tolerance test

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects: age 20-70 BMI ≥ 18.5 kg/m2
• Mets subjects:
• age 30-70 BMI ≥ 18.5 kg/m2 and at least meet three of the following criterions(NCEP-ATPIII, for Asian Americans)
• Waist circumference ≥ 90 cm (men), ≥ 80 cm (women).
• Total triglyceride ≥ 1.7 mmol/L.
• HDL-c \<1.03 mmol/L in men, \<1.3 mmol/L in women.
• Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.
• Fasting plasma glucose ≥ 5.6 mmol/L.

You may not qualify if:

• clinically diagnosed diabetes or use of anti-diabetic medications;
• clinically diagnosed cardiovascular, kidney, liver, pituitary, alimentary tract, and thyroid diseases, cancer(s), or mental illnesses;
• pregnancy or lactation;
• having gastrointestinal surgery within 1 year, excepting appendicitis or hernia;
• current use of antidepressant(s);
• alcohol consumption \> 40 g/d or other substance abuse;
• severe diarrhea (watery stools ≥ 3 times/day ≥ 3 days or longer) in previous 3 months;
• participating any other studies within previous 3 months.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Shanghai University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Xu Lin, PhD

  Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 22, 2019
• Study Start: December 27, 2019
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

CN (1)