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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
| Life for a Child Program, Diabetes Australia | OTHER |
| The University of New South Wales | OTHER |
| University of Sydney |
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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.
While obesity is a risk factor for metabolic disease, sub cohorts with obesity not complicated by the metabolic syndrome have been described. These so called "metabolically healthy obese" may have reduced risk of type 2 diabetes, cardiovascular disease and all-cause mortality compared with individuals with obesity who present with components of the metabolic syndrome.
Longitudinal studies with diabetes and cardiovascular disease risk endpoints reported that individuals with obesity who are metabolically healthy (MHO) held an intermediate health status, such that they were still worse off than the healthy normal-weight individuals. While there have been studies evaluating the stability of the MHO phenotype over time, no study has reported the durability of insulin-sensitivity per se, as measured by the gold-standard hyperinsulinaemic-euglycaemic clamp. In the present study, we aimed to trace the change in insulin resistance/sensitivity, and to uncover predictors of insulin resistance in older age. The secondary aims were to trace the change in body composition, fat distribution and metabolic markers over time in a well-phenotyped cohort studied approximately 5-6 years apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | 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 | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | 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 | 6 years |
| Waist Circumference |
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Inclusion Criteria:
Exclusion Criteria:
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Participants of two previous separate studies performed at the Garvan Institute of Medical Research (Sydney, Australia) were contacted by postal mail to gauge interest in participating in this follow-up study. In the original studies, exclusion criteria included weight change greater than 2 kg in the preceding 6 months, self-reported regular exercise for periods longer than 60 min/week, treatment with medications known to affect insulin sensitivity or carbohydrate metabolism, known renal, cardiac, or liver disease and current cancer, planning pregnancy, consumption of more than 20 and 40 g/day alcohol for women and men, respectively, and smoking >10 cigarettes/day
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Greenfield, MBBS, PhD | Garvan Institute of Medical Research | Principal Investigator |
| Dorit Samocha-Bonet, MSc, PhD | Garvan Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dorit Samocha-Bonet | Darlinghurst | New South Wales | 2010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23344726 | Background | 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. | |
| 24205333 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lean/Normal Weight | Individuals with BMI < 25 kg/m^2 |
| FG001 | Overweight/Obese Insulin-Sensitive | Individuals with BMI > 25 kg/m^2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender |
| FG002 | Overweight/Obese Insulin-Resistant | Individuals with BMI > 25 kg/m^2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lean/Normal Weight | Individuals with body mass index (BMI)<25 kg/m^2 in the baseline study |
| BG001 | Overweight/Obese Insulin-Sensitive | Individuals with BMI>25 kg/m^2 who were deemed insulin-sensitive at the baseline study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity | 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 | The hyperinsulinemic-euglycemic clamp was performed in a sub-cohort of n=9, 10 and 16 participants who were normal-weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant, respectively | Posted | Median | Inter-Quartile Range | micro mol/min/Kg/mU/L/year | 6 years |
|
Serious and other [non-serious] adverse events were not collected or assessed as part of the study (observational study, no intervention administered)
Not applicable (see above)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lean/Normal Weight | Individuals with BMI < 25 kg/m2 | 0 |
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The study is limited by the small sample size, and the potential bias relating to populations likely to volunteer to studies which may have affected the findings. Furthermore, some data were missing for some individuals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dorit Samocha-Bonet | Garvan Institute of Medical Research | +61292958309 | d.samochabonet@garvan.org.au |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| St Vincent's Hospital, Sydney | OTHER |
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Serum, plasma, subcutaneous abdominal fat, skeletal muscle
Change in waist circumference was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart
| 6 years |
| Body Fat Mass | 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 | 6 years |
| Body FFM | 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 | 6 years |
| Visceral Fat Volume | 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 | 6 years |
| Systolic Blood Pressure | Change in Systolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | 6 years |
| Diastolic Blood Pressure | Change in Diastolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | 6 years |
| Fasting Blood Glucose | Change in fasting blood glucose was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | 6 years |
| Fasting Serum Insulin | Change in fasting serum insulin was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | 6 years |
| Background |
| 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. |
| 20461357 | Background | 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. |
| 31071971 | Result | 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. |
| BG002 | Overweight/Obese Insulin-Resistant | Individuals with BMI>25 kg/m^2 who were deemed insulin-resistant at the baseline study |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
Individuals with BMI>25 kg/m2 who were deemed insulin-sensitive at the baseline study
| OG002 | Overweight/Obese Insulin-Resistant | Individuals with BMI>25 kg/m2 who were deemed insulin-resistant at the baseline study |
|
|
| Secondary | Body Mass Index | 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 | All individuals who were followed up after 6 years were analyzed | Posted | Median | Inter-Quartile Range | kg/m^2/year | 6 years |
|
|
|
| Secondary | Waist Circumference | Change in waist circumference was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | All individuals who were followed up after 6 years were analyzed | Posted | Median | Inter-Quartile Range | cm/year | 6 years |
|
|
|
| Secondary | Body Fat Mass | 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 | DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively | Posted | Median | Inter-Quartile Range | % of total body mass/year | 6 years |
|
|
|
| Secondary | Body FFM | 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 | DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively | Posted | Median | Inter-Quartile Range | kg/year | 6 years |
|
|
|
| Secondary | Visceral Fat Volume | 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 | Visceral fat volume was available in n=11, 10 and 18 normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants who undergone a DXA measure due to technical reasons | Posted | Median | Inter-Quartile Range | cm^3/year | 6 years |
|
|
|
| Secondary | Systolic Blood Pressure | Change in Systolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | All individuals who were followed up after 6 years were analyzed | Posted | Median | Inter-Quartile Range | mmHg/year | 6 years |
|
|
|
| Secondary | Diastolic Blood Pressure | Change in Diastolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | All individuals who were followed up after 6 years were analyzed | Posted | Median | Inter-Quartile Range | mmHg/year | 6 years |
|
|
|
| Secondary | Fasting Blood Glucose | Change in fasting blood glucose was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | Fasting blood glucose concentration measure was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively | Posted | Median | Inter-Quartile Range | mmol/L/year | 6 years |
|
|
|
| Secondary | Fasting Serum Insulin | Change in fasting serum insulin was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart | Fasting serum insulin measurement was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively | Posted | Median | Inter-Quartile Range | mU/L/year | 6 years |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Overweight/Obese Insulin-Sensitive | Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Overweight/Obese Insulin-Resistant | Those with BMI > 25 kg/m2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender | 0 | 0 | 0 | 0 | 0 | 0 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |