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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Osteoporosis

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.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117599
    • Clinical Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Post menopausal women

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Measured using Air Displacement Plethysmograph (BOD POD)	1 hour
Body composition	Measured using Dual Energy X-Ray Absorptiometry	1 hour
Body composition	Measured using Magnetic Resonance Imaging (MRI)	1 hour
Bone mineral density	Measured using Dual Energy X-Ray Absorptiometry (DEXA)	Half an hour
Bone mineral density	Measured using Quantitative Computed Tomography	Half an hour
Bone mineral density	Measured using Magnetic Resonance Imaging (MRI)	Half an hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biomarkers	Measure of fasting blood glucose	Half an hour
Blood biomarkers	Measure of fasting blood insulin	Half an hour
Blood biomarkers	Measure of fasting blood lipid profile	Half an hour
Blood biomarkers	Measure of fasting apolipoprotein A1	Half an hour
Blood biomarkers	Measure of fasting apolipoprotein B	Half an hour
Blood biomarkers	Measure of folate	Half an hour
Blood biomarkers	Measure of vitamin B12	Half an hour
Blood biomarkers	Measure of high-sensitive C-reactive protein	Half an hour
Blood biomarkers	Measure of Parathyroid hormone	Half an hour
Urine Markers	Measure urinary C-telopeptide of type II collagen	Half an hour

Collaborators and Investigators

• Sponsor: JeyaKumar Henry
• Collaborators: University of Auckland, New Zealand; Massey University; Institute of Materials Research and Engineering (IMRE)

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Musculoskeletal Diseases; Insulin Resistance; Hyperinsulinism; Bone Diseases; Bone Diseases, Metabolic; Metabolic Syndrome; Prediabetic State; Osteoporosis
• Other Study ID Numbers: 2014/01066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No