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Clinical Trials/NCT03503552
NCT03503552
Completed
Not Applicable

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

JeyaKumar Henry1 site in 1 country97 target enrollmentFebruary 13, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
JeyaKumar Henry
Enrollment
97
Locations
1
Primary Endpoint
Bone mineral density
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2015
End Date
February 2016
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
JeyaKumar Henry
Responsible Party
Sponsor Investigator
Principal Investigator

JeyaKumar Henry

Principal Investigator

Clinical Nutrition Research Centre, Singapore

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Bone mineral density

Time Frame: Half an hour

Measured using Magnetic Resonance Imaging (MRI)

Body composition

Time Frame: 1 hour

Measured using Magnetic Resonance Imaging (MRI)

Secondary Outcomes

  • Urine Markers(Half an hour)
  • Blood biomarkers(Half an hour)

Study Sites (1)

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