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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02017210
Registration number
NCT02017210
Ethics application status
Date submitted
9/12/2013
Date registered
20/12/2013
Date last updated
24/02/2020
Titles & IDs
Public title
Insulin-sensitive Obesity: Lessons From Longitudinal Data
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Scientific title
Insulin-sensitive Obesity: Prospective and Interventional Studies
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Secondary ID [1]
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ISOS (SVH 13/143)
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Universal Trial Number (UTN)
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Trial acronym
ISOS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insulin Sensitivity/Resistance
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Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Lean/normal weight - Individuals with body mass index (BMI)<25 kg/m^2 in the baseline study
Overweight/Obese Insulin-Sensitive - Individuals with BMI>25kg/m^2 who were deemed insulin-sensitive by the hyperinsulinemic -euglycemic clamp (with M/I value above median for men and women separately)
Overweight/Obese Insulin-Resistant - Individuals with BMI>25kg/m^2 who were deemed insulin-resistant by the hyperinsulinemic -euglycemic clamp (with M/I value under median for men and women separately)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Insulin Sensitivity
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Assessment method [1]
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The change in insulin sensitivity (as measured by M-value normalised to insulin from hyperinsulinemic-euglycemic clamp) was determined "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [1]
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6 years
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Secondary outcome [1]
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Body Mass Index
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Assessment method [1]
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Change in body mass index (BMI) was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [1]
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6 years
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Secondary outcome [2]
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Waist Circumference
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Assessment method [2]
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Change in waist circumference was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [2]
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6 years
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Secondary outcome [3]
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Body Fat Mass
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Assessment method [3]
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Body fat mass from dual-energy X-ray absorptiometry (DXA) change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [3]
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6 years
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Secondary outcome [4]
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Body FFM
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Assessment method [4]
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Body fat-free mass (FFM) from DXA change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [4]
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6 years
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Secondary outcome [5]
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Visceral Fat Volume
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Assessment method [5]
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Abdominal visceral fat volume from DXA change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [5]
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6 years
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Secondary outcome [6]
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Systolic Blood Pressure
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Assessment method [6]
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Change in Systolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [6]
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6 years
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Secondary outcome [7]
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Diastolic Blood Pressure
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Assessment method [7]
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Change in Diastolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [7]
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6 years
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Secondary outcome [8]
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Fasting Blood Glucose
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Assessment method [8]
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Change in fasting blood glucose was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [8]
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6 years
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Secondary outcome [9]
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Fasting Serum Insulin
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Assessment method [9]
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Change in fasting serum insulin was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
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Timepoint [9]
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6 years
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Eligibility
Key inclusion criteria
- Participation in two previous studies conducted at the Garvan Institute of Medical
Research Clinical Research Facility (described in the other publications 1-3).
- Willingness to give written informed consent and willingness to participate in the
study.
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Minimum age
26
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Pregnant and/or lactating women.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Dorit Samocha-Bonet - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Funding & Sponsors
Primary sponsor type
Other
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Name
Garvan Institute of Medical Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of Hong Kong
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Diabetes Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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The University of New South Wales
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Sydney
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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St Vincent's Hospital, Sydney
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
People who are overweight and/or obese are at risk of insulin resistance and type 2 diabetes.
However, research has shown that some overweight and/or obese individuals remain
insulin-sensitive and metabolically healthy despite their unhealthy body weight.
The investigators hypothesise that overweight and/or obese people who were deemed
insulin-sensitive in previous studies will maintain their insulin sensitivity and metabolic
health over time. The investigators also hypothesise that the preservation of insulin
sensitivity will be accompanied by key metabolic health markers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02017210
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Trial related presentations / publications
Tonks KT, Ng Y, Miller S, Coster AC, Samocha-Bonet D, Iseli TJ, Xu A, Patrick E, Yang JY, Junutula JR, Modrusan Z, Kolumam G, Stockli J, Chisholm DJ, James DE, Greenfield JR. Impaired Akt phosphorylation in insulin-resistant human muscle is accompanied by selective and heterogeneous downstream defects. Diabetologia. 2013 Apr;56(4):875-85. doi: 10.1007/s00125-012-2811-y. Epub 2013 Jan 24.
Heilbronn LK, Campbell LV, Xu A, Samocha-Bonet D. Metabolically protective cytokines adiponectin and fibroblast growth factor-21 are increased by acute overfeeding in healthy humans. PLoS One. 2013 Oct 18;8(10):e78864. doi: 10.1371/journal.pone.0078864. eCollection 2013.
Samocha-Bonet D, Campbell LV, Viardot A, Freund J, Tam CS, Greenfield JR, Heilbronn LK. A family history of type 2 diabetes increases risk factors associated with overfeeding. Diabetologia. 2010 Aug;53(8):1700-8. doi: 10.1007/s00125-010-1768-y. Epub 2010 May 12.
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Public notes
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Contacts
Principal investigator
Name
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Jerry R Greenfield, MBBS, PhD
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Address
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Garvan Institute of Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02017210
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