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Abstract
Introduction Sex hormone binding globulin (SHBG) levels are reported to be inversely associated with diabetes risk. It is unknown whether diabetes prevention interventions increase SHBG and whether resultant changes in SHBG affect diabetes risk. The purpose of this analysis was to determine whether intensive lifestyle intervention (ILS) or metformin changed circulating SHBG and if resultant changes influenced diabetes risk in the Diabetes Prevention Program (DPP).
Research design and methods This is a secondary analysis from the DPP (1996–2001), a randomized trial of ILS or metformin versus placebo on diabetes risk over a mean follow-up of 3.2 years. The DPP was conducted across 27 academic study centers in the USA. Men, premenopausal and postmenopausal women without hormone use in the DPP were evaluated. The DPP included overweight/obese persons with elevated fasting glucose and impaired glucose tolerance. Main outcomes measures were changes in SHBG levels at 1 year and risk of diabetes over 3 years.
Results ILS resulted in significantly higher increases (postmenopausal women: p<0.01) or smaller decrements (men: p<0.05; premenopausal women: p<0.01) in SHBG compared with placebo or metformin. Changes in SHBG were primarily attributable to changes in adiposity. There were no consistent associations of change in SHBG with the risk of diabetes by treatment arm or participant group.
Conclusions Lifestyle intervention may be associated with favorable changes in circulating SHBG, which is largely due to changes in adiposity. Changes in circulating SHBG do not independently predict reductions in diabetes incidence.
- diabetes mellitus
- type 2
- primary prevention
- hormone
- life style
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Contributors The manuscript was conceived by VRA and KJM, with manuscript questions and analytic plan designed by VRA, CAC, CK, SLE and KJM. VRA wrote the manuscript, interpreted the data, critically reviewed and revised the manuscript. CAC contributed to writing, data analysis, data interpretation, critical review and revision. SLE contributed to data analysis, data interpretation, critical review and revision. LP, CK, SHG, EH and KJM contributed to data interpretation, critical review and revision. All authors had access to the data and all authors agreed to submit the final manuscript. At the time of publication KJM was a full-time employee of Eli Lilly and Company. However, prior to employment at Eli Lilly and Company, KJM served as Principal Investigator for this NIH funded study. As such, data collection occurred prior to and independent of this employment and therefore, data analysis and preparation of the manuscript were independent of Eli Lilly and Company.
Funding The DPP/DPPOS was funded by National Institute of Diabetes and Digestive and Kidney Disease, award U01 DK048489.
Disclaimer The opinions expressed are those of the investigators and do not necessarily reflect the views of the funding agencies. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval All 27 DPP clinical study centers, as well as the DPP Coordinating Center, had institutional review board approvals.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. In accordance with the NIH Public Access Policy, we continue to provide all manuscripts to PubMed Central including this manuscript. DPP/DPPOS has provided the protocols and lifestyle and medication intervention manuals to the public through its public website (https://www.dppos.org). The DPPOS abides by the NIDDK data sharing policy and implementation guidance as required by the NIH/NIDDK (https://www.niddkrepository.org/studies/dppos/)
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