Insulin-sensitive Obesity: Lessons From Longitudinal Data

NCT ID: NCT02017210

Last Updated: 2020-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insulin Sensitivity/Resistance Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lean/normal weight

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

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Life for a Child Program, Diabetes Australia

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role collaborator

St Vincent's Hospital, Sydney

OTHER

Sponsor Role collaborator

Garvan Institute of Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Dorit Samocha-Bonet

Group leader Clinical Insulin Resistance Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry R Greenfield, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Garvan Institute of Medical Research

Dorit Samocha-Bonet, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Garvan Institute of Medical Research

Locations

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Dorit Samocha-Bonet

Darlinghurst, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 23344726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24205333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20461357 (View on PubMed)

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.

Reference Type RESULT
PMID: 31071971 (View on PubMed)

Other Identifiers

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ISOS (SVH 13/143)

Identifier Type: -

Identifier Source: org_study_id

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