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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503552
Other study ID # 2014/01066
Secondary ID
Status Completed
Phase
First received March 26, 2018
Last updated April 18, 2018
Start date February 13, 2015
Est. completion date February 2016

Study information

Verified date April 2018
Source Clinical Nutrition Research Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years to 70 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Singapore Clinical Nutrition Research Centre Singapore

Sponsors (4)

Lead Sponsor Collaborator
JeyaKumar Henry Institute of Materials Research and Engineering (IMRE), Massey University, University of Auckland, New Zealand

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body composition Measured using Air Displacement Plethysmograph (BOD POD) 1 hour
Primary Body composition Measured using Dual Energy X-Ray Absorptiometry 1 hour
Primary Body composition Measured using Magnetic Resonance Imaging (MRI) 1 hour
Primary Bone mineral density Measured using Dual Energy X-Ray Absorptiometry (DEXA) Half an hour
Primary Bone mineral density Measured using Quantitative Computed Tomography Half an hour
Primary Bone mineral density Measured using Magnetic Resonance Imaging (MRI) Half an hour
Secondary Blood biomarkers Measure of fasting blood glucose Half an hour
Secondary Blood biomarkers Measure of fasting blood insulin Half an hour
Secondary Blood biomarkers Measure of fasting blood lipid profile Half an hour
Secondary Blood biomarkers Measure of fasting apolipoprotein A1 Half an hour
Secondary Blood biomarkers Measure of fasting apolipoprotein B Half an hour
Secondary Blood biomarkers Measure of folate Half an hour
Secondary Blood biomarkers Measure of vitamin B12 Half an hour
Secondary Blood biomarkers Measure of high-sensitive C-reactive protein Half an hour
Secondary Blood biomarkers Measure of Parathyroid hormone Half an hour
Secondary Urine Markers Measure urinary C-telopeptide of type II collagen Half an hour
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