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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Insulin-sensitive Obesity: Prospective and Interventional Studies
Secondary ID [1] 0 0
ISOS (SVH 13/143)
Universal Trial Number (UTN)
Trial acronym
ISOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Sensitivity/Resistance 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin Sensitivity
Timepoint [1] 0 0
6 years
Secondary outcome [1] 0 0
Body Mass Index
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Waist Circumference
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Body Fat Mass
Timepoint [3] 0 0
6 years
Secondary outcome [4] 0 0
Body FFM
Timepoint [4] 0 0
6 years
Secondary outcome [5] 0 0
Visceral Fat Volume
Timepoint [5] 0 0
6 years
Secondary outcome [6] 0 0
Systolic Blood Pressure
Timepoint [6] 0 0
6 years
Secondary outcome [7] 0 0
Diastolic Blood Pressure
Timepoint [7] 0 0
6 years
Secondary outcome [8] 0 0
Fasting Blood Glucose
Timepoint [8] 0 0
6 years
Secondary outcome [9] 0 0
Fasting Serum Insulin
Timepoint [9] 0 0
6 years

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.
Minimum age
26 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant and/or lactating women.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dorit Samocha-Bonet - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Hong Kong
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Diabetes Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of New South Wales
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Sydney
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
St Vincent's Hospital, Sydney
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02017210
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.
Tang A, Coster ACF, Tonks KT, Heilbronn LK, Pocock N, Purtell L, Govendir M, Blythe J, Zhang J, Xu A, Chisholm DJ, Johnson NA, Greenfield JR, Samocha-Bonet D. Longitudinal Changes in Insulin Resistance in Normal Weight, Overweight and Obese Individuals. J Clin Med. 2019 May 8;8(5):623. doi: 10.3390/jcm8050623.
Public notes

Contacts
Principal investigator
Name 0 0
Jerry R Greenfield, MBBS, PhD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02017210