OsteoporosisNCT03503552
Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
An observational study of Osteoporosis and Metabolic Syndrome, run by JeyaKumar Henry at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Metabolic Syndrome
- How many people
- 97 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Feb 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post menopausal women
Who may be able to join
- Healthy Chinese women
- Aged 55 to 70 years
- Be 5 years past menopause
- Have not been diagnosed with type 1 diabetes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoporosis, Metabolic Syndrome
- Medical subject headings
- Osteoporosis, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Measured using Air Displacement Plethysmograph (BOD POD)
Measured: 1 hour
Body composition
Measured using Dual Energy X-Ray Absorptiometry
Measured: 1 hour
Body composition
Measured using Magnetic Resonance Imaging (MRI)
Measured: 1 hour
Bone mineral density
Measured using Dual Energy X-Ray Absorptiometry (DEXA)
Measured: Half an hour
Bone mineral density
Measured using Quantitative Computed Tomography
Measured: Half an hour
Bone mineral density
Measured using Magnetic Resonance Imaging (MRI)
Measured: Half an hour
Secondary outcomes (10)
Blood biomarkers
Measure of fasting blood glucose
Measured: Half an hour
Blood biomarkers
Measure of fasting blood insulin
Measured: Half an hour
Blood biomarkers
Measure of fasting blood lipid profile
Measured: Half an hour
Blood biomarkers
Measure of fasting apolipoprotein A1
Measured: Half an hour
Blood biomarkers
Measure of fasting apolipoprotein B
Measured: Half an hour
Blood biomarkers
Measure of folate
Measured: Half an hour
Blood biomarkers
Measure of vitamin B12
Measured: Half an hour
Blood biomarkers
Measure of high-sensitive C-reactive protein
Measured: Half an hour
Blood biomarkers
Measure of Parathyroid hormone
Measured: Half an hour
Urine Markers
Measure urinary C-telopeptide of type II collagen
Measured: Half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start13 Feb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- JeyaKumar Henry
- Sponsor type
- Other government
- Collaborators
- University of Auckland, New Zealand, Massey University, Institute of Materials Research and Engineering (IMRE)
- Responsible party
- Sponsor-investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503552
- Sponsor's protocol ID
- 2014/01066
- Other IDs
- 2014
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
- ClinicalTrials.gov ID
- NCT03503552
- Acronym / sponsor ID
- 2014/01066
- Conditions
- Osteoporosis, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- JeyaKumar HenryOther government
- Collaborators
- University of Auckland, New Zealand, Massey University, Institute of Materials Research and Engineering (IMRE)
- Study start
- 13 Feb 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post menopausal women
Key inclusion criteria (4 listed)
- Healthy Chinese women
- Aged 55 to 70 years
- Be 5 years past menopause
- Have not been diagnosed with type 1 diabetes
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition
Time frame: 1 hour
Measured using Air Displacement Plethysmograph (BOD POD)
Body composition
Time frame: 1 hour
Measured using Dual Energy X-Ray Absorptiometry
Body composition
Time frame: 1 hour
Measured using Magnetic Resonance Imaging (MRI)
Bone mineral density
Time frame: Half an hour
Measured using Dual Energy X-Ray Absorptiometry (DEXA)
Bone mineral density
Time frame: Half an hour
Measured using Quantitative Computed Tomography
Bone mineral density
Time frame: Half an hour
Measured using Magnetic Resonance Imaging (MRI)
10 secondary outcomes
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Blood biomarkers
Time frame: Half an hour
Urine Markers
Time frame: Half an hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Metabolic Syndrome, run by JeyaKumar Henry at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.