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Clinical Trials/NCT02017210
NCT02017210
Completed
Not Applicable

Insulin-sensitive Obesity: Prospective and Interventional Studies

Garvan Institute of Medical Research1 site in 1 country57 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Sensitivity/Resistance
Sponsor
Garvan Institute of Medical Research
Enrollment
57
Locations
1
Primary Endpoint
Insulin Sensitivity
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dorit Samocha-Bonet

Group leader Clinical Insulin Resistance Group

Garvan Institute of Medical Research

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Insulin Sensitivity

Time Frame: 6 years

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

Secondary Outcomes

  • Body Mass Index(6 years)
  • Visceral Fat Volume(6 years)
  • Diastolic Blood Pressure(6 years)
  • Waist Circumference(6 years)
  • Body Fat Mass(6 years)
  • Fasting Blood Glucose(6 years)
  • Body FFM(6 years)
  • Systolic Blood Pressure(6 years)
  • Fasting Serum Insulin(6 years)

Study Sites (1)

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