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Completed

NCT Number: NCT03503552

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

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.

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Key information

Age range

55 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Body composition

    Time frame: 1 hour

    Measured using Air Displacement Plethysmograph (BOD POD)

  2. Body composition

    Time frame: 1 hour

    Measured using Dual Energy X-Ray Absorptiometry

  3. Body composition

    Time frame: 1 hour

    Measured using Magnetic Resonance Imaging (MRI)

  4. Bone mineral density

    Time frame: Half an hour

    Measured using Dual Energy X-Ray Absorptiometry (DEXA)

  5. Bone mineral density

    Time frame: Half an hour

    Measured using Quantitative Computed Tomography

  6. Bone mineral density

    Time frame: Half an hour

    Measured using Magnetic Resonance Imaging (MRI)

Secondary outcomes

  1. Blood biomarkers

    Time frame: Half an hour

    Measure of fasting blood glucose

  2. Blood biomarkers

    Time frame: Half an hour

    Measure of fasting blood insulin

  3. Blood biomarkers

    Time frame: Half an hour

    Measure of fasting blood lipid profile

  4. Blood biomarkers

    Time frame: Half an hour

    Measure of fasting apolipoprotein A1

  5. Blood biomarkers

    Time frame: Half an hour

    Measure of fasting apolipoprotein B

  6. Blood biomarkers

    Time frame: Half an hour

    Measure of folate

  7. Blood biomarkers

    Time frame: Half an hour

    Measure of vitamin B12

  8. Blood biomarkers

    Time frame: Half an hour

    Measure of high-sensitive C-reactive protein

  9. Blood biomarkers

    Time frame: Half an hour

    Measure of Parathyroid hormone

  10. Urine Markers

    Time frame: Half an hour

    Measure urinary C-telopeptide of type II collagen

Sponsors and collaborators

Lead sponsor

JeyaKumar Henry

Other Gov

Collaborators

  • Institute of Materials Research and Engineering (IMRE)
  • Massey University
  • University of Auckland, New Zealand

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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