Trial record 10 of 37 for:    Open Studies | "Weight Reduction Programs"

Insulin-sensitive Obesity: Lessons From Follow up and Weight Loss Interventions (ISOS)

This study is currently recruiting participants.
Verified December 2013 by Garvan Institute of Medical Research
Sponsor:
Collaborators:
Diabetes Australia
Baker IDI Heart and Diabetes Institute
Chinese University of Hong Kong
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT02017210
First received: December 9, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

STUDY PART 1 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.

STUDY PART 2 The cause of insulin resistance is potentially related to special fats (sphingolipids) within the skeletal muscle. Insulin resistance usually improves after weight loss but it is not yet known how these sphingolipids behave.

The investigators hypothesise that improvement in insulin sensitivity with calorie restriction and weight loss will be coupled with decreases in specific skeletal muscle sphingolipids.


Condition Intervention
Insulin Sensitivity/Resistance
Obesity
Weight Loss
Other: PART 2: 12 week calorie restriction weight loss program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Insulin-sensitive Obesity: Prospective and Interventional Studies

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

    PART 1: OBSERVATIONAL

    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.


  • change in insulin sensitivity [ Time Frame: change in insulin sensitivity at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]

    PART 2: INTERVENTIONAL

    Weight loss intervention will be 12 weeks of supervised calorie restriction. Insulin sensitivity will be measured at baseline and in week 13.



Secondary Outcome Measures:
  • change in weight, height, BMI, waist and hip circumference [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in total body fat and distribution [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in fasting insulin, c-peptide, glucose levels [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in HbA1c, 75g oral glucose tolerance [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in fasting non-esterified fatty acids, lipids, plasma and LDL lipidomics [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in skeletal muscle lipidomics [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
    Mass spectrometry will be used to characterise skeletal muscle lipidomics.

  • change in circulating adipokines and hepatokines [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in inflammatory markers [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in energy expenditure [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
    Indirect calorimetry will be used to measure energy expenditure

  • change in arterial stiffness [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in heart rate variability [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in subcutaneous fat cell size [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in blood pressure [ Time Frame: PART 1: change at follow up compared to 6 years ago ] [ Designated as safety issue: No ]
  • change in weight, height, BMI, waist and hip circumference [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in total body fat and distribution [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in fasting insulin, c-peptide, glucose levels [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in HbA1c, 75g oral glucose tolerance [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in fasting non-esterified fatty acids, lipids, plasma and LDL lipidomics [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in skeletal muscle lipidomics [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
    Mass spectrometry will be used to characterise skeletal muscle lipidomics.

  • change in circulating adipokines and hepatokines [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in inflammatory markers [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in energy expenditure [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
    Indirect calorimetry will be used to measure energy expenditure.

  • change in arterial stiffness [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in heart rate variability [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in subcutaneous fat cell size [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]
  • change in blood pressure [ Time Frame: PART 2: change at week 13 after weight loss compared to baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: November 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PART 1: Longitudinal follow up, PART 2: Weight loss
Participant's metabolic parameters are followed up after approximately 6 years and those with a BMI over 25 will be additionally followed up after a 12 week calorie restriction weight loss program. Participant's metabolic parameters are measured before and after the weight loss program.
Other: PART 2: 12 week calorie restriction weight loss program

  Eligibility

Ages Eligible for Study:   26 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

PART 1

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.

PART 2

Inclusion Criteria:

  • BMI 25 - 45 kg/m2
  • Willingness to give written informed consent and willingness to participate in and comply with the study.
  • For newly recruited participants via adverts

    • age 40-70 years

Exclusion Criteria:

  • Current smoker
  • Weight change > 2kg in the preceding 6 months
  • Exercise > 60 min/week
  • Alcohol intake > 20 g/day
  • Severe known renal, cardiac and/or liver disease
  • For newly recruited participants via adverts

    • Diabetes mellitus
  • For those who participated in the previous SiDIRAD or EXCESS studies and have known diabetes

    • HbA1c more than 9%
    • Presence of diabetes complications
    • On other medications for diabetes apart from metformin, a sulphonylurea or a DPP4-inhibitor
  • Individuals who are treated with medications known to affect insulin sensitivity and/or carbohydrate metabolism (e.g. steroids)
  • Pregnant and/or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017210

Contacts
Contact: Alice Tang, BSc(Med) MBBS +61 2 9295 8218 a.tang@garvan.org.au

Locations
Australia, New South Wales
Garvan Institute of Medical Research Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Alice Tang, BSc(Med) MBBS    +61 2 9295 8218    a.tang@garvan.org.au   
Principal Investigator: Jerry R Greenfield, BSc(Med) MBBS PhD FRACP         
Principal Investigator: Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD         
Sub-Investigator: Alice Tang, BSc(Med) MBBS         
Sub-Investigator: Lesley V Campbell, MBBS MRACP MRCP FRACP FRCP         
Sub-Investigator: Katherine Tonks, BSc(Med) MBBS MPH FRACP         
Sponsors and Collaborators
Dr Jerry Greenfield
Diabetes Australia
Baker IDI Heart and Diabetes Institute
Chinese University of Hong Kong
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: Dr Jerry Greenfield, Group leader, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT02017210     History of Changes
Other Study ID Numbers: ISOS (SVH 13/143)
Study First Received: December 9, 2013
Last Updated: December 16, 2013
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014