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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503552
• Other study ID #: 2014/01066
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Osteoporosis
• Prediabetic State

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