NCT03503552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

March 26, 2018

Last Update Submit

April 18, 2018

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (10)

  • Blood biomarkers

    Half an hour

  • Blood biomarkers

    Half an hour

  • Blood biomarkers

    Half an hour

  • Blood biomarkers

    Half an hour

  • Blood biomarkers

    Half an hour

  • +5 more secondary outcomes

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly post menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post menopausal women

You may qualify if:

  • Healthy Chinese women
  • Aged 55 to 70 years
  • Be 5 years past menopause
  • Have not been diagnosed with type 1 diabetes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

OsteoporosisMetabolic Syndrome

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 20, 2018

Study Start

February 13, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations