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Completed

NCT Number: NCT02017210

Insulin-sensitive Obesity: Lessons From Longitudinal Data

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.

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Key information

Age range

26 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dorit Samocha-Bonet

Darlinghurst, New South Wales, 2010, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Body Mass Index

    Time frame: 6 years

    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

  2. Waist Circumference

    Time frame: 6 years

    Change in waist circumference was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

  3. Body Fat Mass

    Time frame: 6 years

    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

  4. Body FFM

    Time frame: 6 years

    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

  5. Visceral Fat Volume

    Time frame: 6 years

    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. Systolic Blood Pressure

    Time frame: 6 years

    Change in Systolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

  7. Diastolic Blood Pressure

    Time frame: 6 years

    Change in Diastolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

  8. Fasting Blood Glucose

    Time frame: 6 years

    Change in fasting blood glucose was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

  9. Fasting Serum Insulin

    Time frame: 6 years

    Change in fasting serum insulin was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Sponsors and collaborators

Lead sponsor

Garvan Institute of Medical Research

Other

Collaborators

  • Life for a Child Program, Diabetes Australia
  • St Vincent's Hospital, Sydney
  • The University of Hong Kong
  • The University of New South Wales
  • University of Sydney

Registry information

Official study title

Insulin-sensitive Obesity: Prospective and Interventional Studies

Acronym: ISOS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2013
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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