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Increased Free Testosterone Levels in Men with Uncontrolled Type 2 Diabetes Five Years After Randomization to Bariatric Surgery

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Abstract

Hypogonadism frequently occurs in male patients with type 2 diabetes (T2DM) and is linked to insulin resistance and inflammation. Testosterone levels rise acutely in obese patients following bariatric surgery, though long-term changes have not been investigated in a randomized controlled trial. This study evaluated obese men with T2DM randomized to either bariatric surgery or medical therapy. Testosterone, gonadotropins, body composition, insulin sensitivity, and inflammatory markers were evaluated in 32 patients at baseline and at 5 years. Surgical patients had 47.4% increase in free testosterone compared to medical therapy patients who had 2.2% decrease (P = 0.013). Increase in free testosterone correlated with reduction in body weight, high-sensitivity C-reactive protein (hsCRP), and leptin levels. Prolonged improvements in testosterone levels after bariatric surgery in T2DM are found to be related to reduction in body weight and adipogenic inflammation.

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Acknowledgements

Financial support: Primary funding for the STAMPEDE trial is from Ethicon endo-surgery EES IIS 19900 to PRS. The American Diabetes Association clinical translational award (1-11-26 CT) to SRK provided funding for STAMPEDE for this analysis. A grant from NIH (R01-DK089547) to PRS, SRK, and JPK was provided. Dr. Kashyap had full access to all of the data in the study and takes responsibility for the integrity of the data, the accuracy of the data analysis, and manuscript preparation.

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Authors and Affiliations

  1. Cleveland Clinic Lerner College of Medicine of Case Western Reserve, Cleveland, OH, USA

    Nathan H. Pham, Laurence Kennedy & Sangeeta R. Kashyap

  2. Cleveland Clinic Lerner College of Medicine of Case Western Reserve, Endocrinology and Metabolism Institute, 9500 Euclid Ave, Cleveland, OH, 44195, USA

    James Bena & Sangeeta R. Kashyap

  3. Brigham and Women’s Hospital, Boston, MA, USA

    Deepak L. Bhatt

  4. Harvard Medical School, Boston, MA, USA

    Deepak L. Bhatt

  5. Cleveland Clinic, Bariatric and Metabolic Institute, Cleveland, OH, USA

    Philip R. Schauer

Authors
  1. Nathan H. Pham
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  2. James Bena
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  3. Deepak L. Bhatt
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  4. Laurence Kennedy
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  5. Philip R. Schauer
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  6. Sangeeta R. Kashyap
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Corresponding author

Correspondence to Sangeeta R. Kashyap.

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Conflict of Interest

Nathan Pham reports receiving consulting fees from FundRx; Dr. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda; Dr. Schauer reports receiving consulting fees from Ethicon and Novo Nordisk, lecture fees from Ethicon, Eli Lilly, Nestle, and Global Academy for Medical Education, fees for board membership and stock options or equity from Surgiquest, Barosense, RemedyMD, and SE Healthcare Quality Consulting, fees for providing expert testimony from Physicians Reviews of Surgery regarding complications of surgery, and financial support for a fellowship program from Stryker and having a pending patent application with the Cleveland Clinic regarding medical devices for weight loss; Dr. Kashyap reports receiving consulting fees from Ethicon. James Bena and Dr. Kennedy report no other potential conflict of interest relevant to this article.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Pham, N.H., Bena, J., Bhatt, D.L. et al. Increased Free Testosterone Levels in Men with Uncontrolled Type 2 Diabetes Five Years After Randomization to Bariatric Surgery. OBES SURG 28, 277–280 (2018). https://doi.org/10.1007/s11695-017-2881-5

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  • DOI: https://doi.org/10.1007/s11695-017-2881-5

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