Insulin-sensitive Obesity: Lessons From Longitudinal Data (ISOS)

Garvan Institute of Medical Research

Status: Completed

Conditions: Insulin Sensitivity/Resistance; Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT02017210

ISOS (SVH 13/143)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 26 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

57 participants in 3 patient groups

Lean/normal weight

Description:

Individuals with body mass index (BMI)\<25 kg/m\^2 in the baseline study

Overweight/Obese Insulin-Sensitive

Description:

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

Description:

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)