Clinical trial NCT03503552: Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
Official title: Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Metabolic Syndrome
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: University of Auckland, New Zealand
name: Massey University
name: Institute of Materials Research and Engineering (IMRE)
First posted: 2018-04-20
Enrollment: 97
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post menopausal women

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.

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.

Primary outcomes:
measure: Body composition
timeFrame: 1 hour
measure: Body composition
timeFrame: 1 hour
measure: Body composition
timeFrame: 1 hour
measure: Bone mineral density
timeFrame: Half an hour
measure: Bone mineral density
timeFrame: Half an hour
measure: Bone mineral density
timeFrame: Half an hour
Secondary outcomes:
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Blood biomarkers
timeFrame: Half an hour
measure: Urine Markers
timeFrame: Half an hour
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: