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

Completed

• Conditions: Metabolic Syndrome; Osteoporosis

• Registration Number: NCT03503552
• Lead Sponsor: JeyaKumar Henry

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.

Study Timeline

• Study Start: 2015-02-13
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2018-03-26
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-18
• Last Update Submitted: 2018-04-18
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body composition	1 hour	Measured using Magnetic Resonance Imaging (MRI)
Bone mineral density	Half an hour	Measured using Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
Urine Markers	Half an hour	Measure urinary C-telopeptide of type II collagen
Blood biomarkers	Half an hour	Measure of Parathyroid hormone

Trial Locations

Locations (1)

Clinical Nutrition Research Centre; 🇸🇬 Singapore, Singapore