Insulin-sensitive Obesity: Lessons From Longitudinal Data

Obesity Clinical Trial

— ISOS  

Official title:

Insulin-sensitive Obesity: Prospective and Interventional Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017210
• Other study ID #: ISOS (SVH 13/143)
• Status: Completed
• Start date: November 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2020
• Source: Garvan Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 75 Years

Eligibility

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.

Exclusion Criteria:

• Pregnant and/or lactating women.

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity/Resistance
• Obesity

Locations

Country	Name	City	State
Australia	Dorit Samocha-Bonet	Darlinghurst	New South Wales

Sponsors (6)

Lead Sponsor	Collaborator
Garvan Institute of Medical Research	Diabetes Australia, St Vincent's Hospital, Sydney, The University of Hong Kong, The University of New South Wales, University of Sydney

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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 — View Citation

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, Stöckli 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6 years
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	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	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	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	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	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	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	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	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	6 years