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

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ClinicalTrials.gov Identifier: NCT03503552
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
University of Auckland, New Zealand
Massey University
Institute of Materials Research and Engineering (IMRE)
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Study Description
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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.

Condition or disease
Osteoporosis Metabolic Syndrome

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 Design
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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Other
Time Perspective: Other
Official Title: Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
Actual Study Start Date : February 13, 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Body composition [ Time Frame: 1 hour ]
    Measured using Air Displacement Plethysmograph (BOD POD)

  2. Body composition [ Time Frame: 1 hour ]
    Measured using Dual Energy X-Ray Absorptiometry

  3. Body composition [ Time Frame: 1 hour ]
    Measured using Magnetic Resonance Imaging (MRI)

  4. Bone mineral density [ Time Frame: Half an hour ]
    Measured using Dual Energy X-Ray Absorptiometry (DEXA)

  5. Bone mineral density [ Time Frame: Half an hour ]
    Measured using Quantitative Computed Tomography

  6. Bone mineral density [ Time Frame: Half an hour ]
    Measured using Magnetic Resonance Imaging (MRI)


Secondary Outcome Measures :
  1. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of fasting blood glucose

  2. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of fasting blood insulin

  3. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of fasting blood lipid profile

  4. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of fasting apolipoprotein A1

  5. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of fasting apolipoprotein B

  6. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of folate

  7. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of vitamin B12

  8. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of high-sensitive C-reactive protein

  9. Blood biomarkers [ Time Frame: Half an hour ]
    Measure of Parathyroid hormone

  10. Urine Markers [ Time Frame: Half an hour ]
    Measure urinary C-telopeptide of type II collagen


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only post menopausal women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Post menopausal women
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503552


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
JeyaKumar Henry
University of Auckland, New Zealand
Massey University
Institute of Materials Research and Engineering (IMRE)
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03503552    
Other Study ID Numbers: 2014/01066
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Metabolic Syndrome
Prediabetic State
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diabetes Mellitus
Endocrine System Diseases