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Clinical Trials/NCT05916482
NCT05916482CompletedNot Applicable

Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

University Medical Center Ho Chi Minh City (UMC)2 sites in 1 country502 target enrollmentStarted: July 14, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
502
Locations
2
Primary Endpoint
Hip circumference

Study Overview

Brief Summary

In the past three decades, obesity has emerged insurmountably, not only in affluent nations but also in many low- and middle-income countries worldwide. It has been linked to various non-communicable diseases, including hypertension, coronary heart disease, diabetes mellitus, dyslipidemia, stroke, colorectal cancer, and many other chronic conditions, such as musculoskeletal disorders, putting tremendous pressure on healthcare systems and the socio-economy. The Asia and Pacific region harbors the highest absolute number of people with overweight and obese, amounting to approximately 1 billion. In Southeast Asia, the prevalence of overweight and obesity increased by almost 40% between 1990 and 2013. Although Vietnam has the lowest percentage of obese adults in the region (about 3.6%), we experienced a 38% increase in the number of obese people between 2010-2014, much higher than that in the University Kingdom and the United States (10% and 8% correspondingly). However, the problem is underestimated by not only healthcare professionals but also patients with obesity. These alarms underscore the necessity of implementing a comprehensive assessment and more focused and practical strategies for addressing obesity in Vietnam, where data has been limited. Therefore, our research has two arms: (1) characterization of patients with obesity to identify those at the highest risks for obesity complications, and (2) understating the attitudes and perceptions of people living with obesity to gain insights into the psychological factors associated with obesity. This research will be a foundation for further research on obesity in Vietnam and Southeast Asia.

Detailed Description

All Vietnamese, aged 18-65, diagnosed with obesity defined by BMI ≥ 25 kg/m2 as per Asia-Pacific Guidelines for Obesity, present at University Medical Center Ho Chi Minh City and My Duc General Hospital outpatient clinics, will be enrolled to the study. The patients will have:

  • Standard anthropometric data will be done, using a professional medical HM200P Portable Height Stadiometer and a standardised ISO (International Organization for Standardization) 9001:2015 weight scale, by professional and experienced physicians according to standard study protocol: Weight, height, waist and hip circumference, waist to hip ratio, BMI calculated, followed by World Health Organization guidelines for Asian people.
  • Blood pressure measure.
  • Fat mass measured by the Tanita MC-780 MA (Serial: 17050004).
  • Blood tests: fasting plasma glucose, cholesterol, HDL-C, LDL-C, and triglyceride.
  • Mood disorder screening by answering a Patient Health Questionnaire-9.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subject is diagnosed with obesity defined by BMI ≥ 25 kg/m2

Exclusion Criteria

  • Inability to cooperate with height measurement.
  • Inability to answer questionnaire.

Outcomes

Primary Outcomes

Hip circumference

Time Frame: At baseline

To be measured around the widest portion of the buttocks.

Blood pressure

Time Frame: At baseline

Systolic and diastolic pressure measurements will be taken using a standardized sphygmomanometer.

Height measurement

Time Frame: At baseline

Using a professional medical HM200P Portable Height Stadiometer

Total cholesterol

Time Frame: At baseline

Total cholesterol (mmol/L) concentrations in serum

Weight measurement

Time Frame: At baseline

Using standardized weight scale (ISO 9001:2015)

HDL cholesterol

Time Frame: At baseline

HDL cholesterol (mmol/L) concentrations in serum

LDL cholesterol

Time Frame: At baseline

LDL cholesterol (mmol/L) concentrations in serum

Risk of depression score

Time Frame: At baseline

Risk of depression will be assessed using PHQ-9 (Patient Health Questionnaire-9). It is scored on a 27-point scale. Those with a PHQ-9 score less than five is considered at no risk of depression, and those with a PHQ-9 score equal to or more than 5 are at risk of depression.

Waist circumference

Time Frame: At baseline

To be measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest

Body Mass Index

Time Frame: At baseline

Weight in kilograms divided by height in meters squared

Fasting plasma glucose

Time Frame: At baseline

Fasting plasma glucose (mmol/L) concentrations in serum

Triglycerides

Time Frame: At baseline

Triglycerides (mmol/L) concentrations in serum

Body composition change

Time Frame: At baseline

Body fat mass (% BFM), body fat percentage (%BF), muscle mass, skeletal muscle mass (% SMM) and visceral fat rating will be evaluated to assess body composition change. Measurements will be assessed using a Electrical bioimpedance (BIA)

Secondary Outcomes

  • The relationship between the severity of obesity to body composition(At baseline)
  • The relationship between the severity of obesity to anthropometric parameters(At baseline)
  • The relationship between the severity of obesity to biochemical parameters(At baseline)
  • The relationship between the severity of obesity to risk of depression(At baseline)

Investigators

Sponsor
University Medical Center Ho Chi Minh City (UMC)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tran Quang Nam

Head of department of Endocrinology

University Medical Center Ho Chi Minh City (UMC)

Study Sites (2)

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