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CompletedNCT03503552Updated Apr 20, 2018

Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore

An observational study in Osteoporosis and Metabolic Syndrome, sponsored by JeyaKumar Henry. Completed at 1 site in Singapore. Open to female participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by JeyaKumar Henry · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
97
Ages
55 Years to 70 Years
Sex
Female
01

Study summary

This project aims to ascertain that novel imaging and metabolic markers can be used to identify as well as to validate and improve the detection of Singapore-Chinese women at increased risk of diabetes.

Read the detailed description

Disproportionate non-communicable disease risk present in some ethnicities has been demonstrated and is amplified by increased weight gain. Relative to Malay and Caucasian populations, the prevalence of obesity increased sharply in people of Chinese and Indian ethnicity and diabetes risk is prevalent at a BMI of 21 (equivalent to a BMI >25 in Caucasian populations). It was also speculated that Chinese Singaporean women are prone to metabolic syndrome at a lower BMI. This study will recruit two groups of postmenopausal women with different BMI's and to measure markers for metabolic syndrome. These participants will visit Clinical Nutrition Research Centre for a single session and will undergo a whole body scan and a regional scan of the lumbar spine and femoral neck with a bone densitometer and fasting baseline blood and urine samples collected. Dual Energy X-ray Absorptiometry (DEXA) scan will provide percentage fat mass, fat in gram, whole body bone mineral content and total body lean mass. From these, gynoid and android fat distribution will be derived and appendicular lean mass will be calculated and an index calculated using kg/m2 to give an indication of relative muscle mass. In addition blood and urine samples will be collected for metabolic risk analysis. Participants will be also be undergoing a Quantitative Computed Tomography (QCT) scan which will allow true volumetric measurements of the lumbar spine and proximal femur independent of the body size. Volumetric density values will be measured in Hounsfield units transformed into Bone Mineral Density measurements using a calibration phantom underneath the patient. Magnetic Resonance Imaging of the 3rd lumbar vertebra and the right hip will also be performed.

02

Conditions studied

  • Osteoporosis
  • Metabolic Syndrome
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 97 is below the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

JeyaKumar Henry is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Post menopausal women

Inclusion criteria

  • Healthy Chinese women
  • Aged 55 to 70 years
  • Be 5 years past menopause
  • Have not been diagnosed with type 1 diabetes

Exclusion criteria

Exclusion Criteria:

  • Have been diagnosed with Hyper or Hypo-thyroidism, Parathyroid disease, Diabetes Mellitus, Cushing's syndrome.
  • Have Cancers
  • Have Systemic Lupus Erythematosus and Rheumatoid Arthritis
  • Respiratory Disease
  • Had Operations such as Gastrectomy and Intestinal resection
  • Have Liver Disease such as Liver cirrhosis
  • On prescribed medication known to affect the study outcomes.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
97 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Body composition

    Measured using Air Displacement Plethysmograph (BOD POD)

    Time frame: 1 hour

  2. Body composition

    Measured using Dual Energy X-Ray Absorptiometry

    Time frame: 1 hour

  3. Body composition

    Measured using Magnetic Resonance Imaging (MRI)

    Time frame: 1 hour

  4. Bone mineral density

    Measured using Dual Energy X-Ray Absorptiometry (DEXA)

    Time frame: Half an hour

  5. Bone mineral density

    Measured using Quantitative Computed Tomography

    Time frame: Half an hour

  6. Bone mineral density

    Measured using Magnetic Resonance Imaging (MRI)

    Time frame: Half an hour

Secondary outcomes

  1. Blood biomarkers

    Measure of fasting blood glucose

    Time frame: Half an hour

  2. Blood biomarkers

    Measure of fasting blood insulin

    Time frame: Half an hour

  3. Blood biomarkers

    Measure of fasting blood lipid profile

    Time frame: Half an hour

  4. Blood biomarkers

    Measure of fasting apolipoprotein A1

    Time frame: Half an hour

  5. Blood biomarkers

    Measure of fasting apolipoprotein B

    Time frame: Half an hour

  6. Blood biomarkers

    Measure of folate

    Time frame: Half an hour

  7. Blood biomarkers

    Measure of vitamin B12

    Time frame: Half an hour

  8. Blood biomarkers

    Measure of high-sensitive C-reactive protein

    Time frame: Half an hour

  9. Blood biomarkers

    Measure of Parathyroid hormone

    Time frame: Half an hour

  10. Urine Markers

    Measure urinary C-telopeptide of type II collagen

    Time frame: Half an hour

07

Study locations

1 site
  • Clinical Nutrition Research Centre
    Singapore, 117599, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03503552
Lead sponsor
JeyaKumar Henry
Collaborators
University of Auckland, New Zealand, Massey University, Institute of Materials Research and Engineering (IMRE)
Responsible party
JeyaKumar Henry (Principal Investigator, Singapore Institute of Food and Biotechnology Innovation) — Sponsor-investigator
First posted
Apr 20, 2018
Start date
Feb 13, 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 20, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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