Insulin-sensitive Obesity: Lessons From Longitudinal Data

NCT02017210 | Completed Results

• 1 other identifier: ISOS (SVH 13/143)
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity/Resistance; Obesity

Keywords

Hyperinsulinaemic-euglycaemic clamp; Body fat composition; Dual-energy x-ray absorptiometry; Obesity; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  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

  6 years

Secondary Outcomes (9)

• Body Mass Index

  6 years

• Waist Circumference

  6 years

• Body Fat Mass

  6 years

• Body FFM

  6 years

• Visceral Fat Volume

  6 years

Study Arms (3)

Lean/normal weight

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

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)

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)

Eligibility Criteria

• Age: 26 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of two previous separate studies performed at the Garvan Institute of Medical Research (Sydney, Australia) were contacted by postal mail to gauge interest in participating in this follow-up study. In the original studies, exclusion criteria included weight change greater than 2 kg in the preceding 6 months, self-reported regular exercise for periods longer than 60 min/week, treatment with medications known to affect insulin sensitivity or carbohydrate metabolism, known renal, cardiac, or liver disease and current cancer, planning pregnancy, consumption of more than 20 and 40 g/day alcohol for women and men, respectively, and smoking \>10 cigarettes/day

You may qualify if:

• 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.

You may not qualify if:

• Pregnant and/or lactating women.

Sponsors & Collaborators

• Garvan Institute of Medical Research: lead
• The University of Hong Kong: collaborator
• Life for a Child Program, Diabetes Australia: collaborator
• The University of New South Wales: collaborator
• University of Sydney: collaborator
• St Vincent's Hospital, Sydney: collaborator

Study Sites (1)

Dorit Samocha-Bonet

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (4)

• 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.

  PMID: 23344726 BACKGROUND

• 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.

  PMID: 24205333 BACKGROUND

• 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.

  PMID: 20461357 BACKGROUND

• 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.

  PMID: 31071971 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, subcutaneous abdominal fat, skeletal muscle

MeSH Terms

Conditions

Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study is limited by the small sample size, and the potential bias relating to populations likely to volunteer to studies which may have affected the findings. Furthermore, some data were missing for some individuals.

Results Point of Contact

• Title: Dr. Dorit Samocha-Bonet
• Organization: Garvan Institute of Medical Research

d.samochabonet@garvan.org.au

+61292958309

Study Officials

• Jerry R Greenfield, MBBS, PhD

  Garvan Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Dorit Samocha-Bonet, MSc, PhD

  Garvan Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group leader Clinical Insulin Resistance Group

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)