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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02017210
First Posted: December 20, 2013
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Baker IDI Heart and Diabetes Institute
Chinese University of Hong Kong
Diabetes Australia
Information provided by (Responsible Party):
Dorit Samocha-Bonet, Garvan Institute of Medical Research
  Purpose

People who are overweight and/or obese usually are insulin resistant and so are at risk of type 2 diabetes. However, research has shown that some overweight and/or obese people remain insulin sensitive and healthy despite their weight.

The investigators hypothesise that insulin-sensitive overweight and/or obese people maintain their insulin sensitivity and metabolic health over time. The investigators also hypothesise that the preservation of insulin sensitivity will be determined by key metabolic factors.


Condition Intervention
Insulin Sensitivity/Resistance Obesity Weight Loss Other: Longitudinal study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Insulin-sensitive Obesity: Prospective and Interventional Studies

Resource links provided by NLM:


Further study details as provided by Dorit Samocha-Bonet, Garvan Institute of Medical Research:

Primary Outcome Measures:
  • Change in insulin sensitivity [ Time Frame: change in insulin sensitivity at follow up compared to 6 years ago ]
    Insulin sensitivity will be assessed in this current follow up study. This will be compared to insulin sensitivity data collected in this study cohort approximately 6 years ago.


Secondary Outcome Measures:
  • Change in anthropometry (weight, height, BMI, waist and hip circumference) [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in total body fat and distribution [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in fasting insulin, c-peptide, glucose levels [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in HbA1c, 75g oral glucose tolerance [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in fasting non-esterified fatty acids and lipids profile [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in circulating adipokines, cytokines and hepatokines [ Time Frame: Change at follow up compared to 6 years ago ]
  • Change in blood pressure [ Time Frame: Change at follow up compared to 6 years ago ]

Enrollment: 68
Study Start Date: November 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Longitudinal follow up
Participant's metabolic parameters are followed up after approximately 6 years.
Other: Longitudinal study
Metabolic health, anthropometry, body fat distribution, liver lipid will be followed up in individuals previously studied at the Clinical Research Facility.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in the previous SiDIRAD (1) or EXCESS (2-6) study.
  • Willingness to give written informed consent and willingness to participate in and comply with the study.

Exclusion Criteria:

  • Pregnant and/or lactating women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017210


Locations
Australia, New South Wales
Garvan Institute of Medical Research
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Garvan Institute of Medical Research
Baker IDI Heart and Diabetes Institute
Chinese University of Hong Kong
Diabetes Australia
Investigators
Principal Investigator: Jerry R Greenfield, BSc(Med) MBBS PhD FRACP Garvan Institute of Medical Research
Principal Investigator: Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD Garvan Institute of Medical Research
  More Information

Publications:

Responsible Party: Dorit Samocha-Bonet, Group leader Clinical Insulin Resistance Group, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT02017210     History of Changes
Other Study ID Numbers: ISOS (SVH 13/143)
First Submitted: December 9, 2013
First Posted: December 20, 2013
Last Update Posted: March 7, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Weight Loss
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases