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Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes

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Abstract

Background

Large-scale randomized clinical trials are needed to assess the role of Roux-en-Y gastric bypass (RYGB) in treating patients with type 2 diabetes mellitus (T2DM). Recruitment challenges must be understood.

Methods

One hundred twenty participants were needed for a prospective randomized controlled trial investigating treatments for hyperglycemia and cardiovascular disease risk factors in patients with T2DM. The trial had two arms—intensive medical management plus a rigorous lifestyle intervention (LS/IMM) versus LS/IMM with RYGB. Medical inclusion criteria included glycosylated hemoglobin (HbA1c) ≥8.0 % while under the care of a physician and body mass index (BMI) 30.0–39.9 kg/m2. Another inclusion criterion was expressed willingness to accept randomization and participate fully. Varied recruitment strategies were employed at four academic hospitals in the USA and Taiwan, including referrals, mass media, direct mail to patients drawn from a practice-based database, and direct mail to commercial mailing lists.

Results

Between February 2008 and December 2011, 2,648 candidates were phone-screened and 240 were screened on site; 120 participants were eventually randomized. Impediments included stringent medical inclusion criteria and a lack of equipoise (i.e., strong beliefs or preferences) among patients and their personal community-based physicians. To meet timeline requirements, the upper limit for BMI was increased from 34.9 to 39.9 kg/m2 and an additional site was added.

Conclusions

We successfully recruited 120 participants with poorly controlled T2DM and mild to moderate obesity. Participants had to be willing to accept randomization to either surgical or nonsurgical treatments. Recruitment took 4 years.

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Abbreviations

BMI:

Body Mass Index

CUMC:

Columbia University Medical Center in New York, NY

DSS:

Diabetes Surgery Study

HbA1c:

Glycated Hemoglobin

Taiwan:

Two closely related clinics in Taiwan

T2DM:

Type 2 diabetes mellitus

Mayo:

Mayo Clinic in Rochester, MN

UMN:

University of Minnesota in Minneapolis, MN

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Conflict of interest statements

All authors except for Dr. Leslie received salary support from Covidien for conducting the study and reporting results. Ms. Thomas, Ms. Bainbridge, Ms. Chen, Dr. Connett, Dr. Lee, Dr. Leslie and Ms. Schone have nothing further to disclose. Dr. Ikramuddin further reports personal fees from Novo Nordisk, personal fees from Medica, personal fees from OptumHealth, personal fees from Metamodix Inc, personal fees from Covidien, grants from EnteroMedics, and grants from Reshape Medical. Dr. Jensen further reports personal fees from Novo-Nordisk, personal fees from Eisai, and personal fees from Vivus. Dr. Korner further reports personal fees from Johnson and Johnson, personal fees from Nutrisystem, personal fees from Federal Trade Commission, and personal fees from Office of Professional Misconduct.

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Authors and Affiliations

  1. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA

    Avis J. Thomas & John E. Connett

  2. Department of Medicine, Columbia University Medical Center, New York, NY, USA

    Heather A. Bainbridge & Judith Korner

  3. Department of Surgery, University of Minnesota, Minneapolis, MN, USA

    Joyce L. Schone, Sayeed Ikramuddin & Daniel B. Leslie

  4. Department of Surgery, Min-Sheng General Hospital, Taoyuan, Taiwan, Republic of China

    Shu-Chun Chen & Wei-Jei Lee

  5. Endocrine Research Unit, Mayo Clinic, Rochester, MN, USA

    Michael D. Jensen

  6. Institute for Education and Research, Health Partners, Bloomington, MN, USA

    Avis J. Thomas

Authors
  1. Avis J. Thomas
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  2. Heather A. Bainbridge
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  3. Joyce L. Schone
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  4. Shu-Chun Chen
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  5. John E. Connett
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  6. Sayeed Ikramuddin
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  7. Wei-Jei Lee
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  8. Michael D. Jensen
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  9. Daniel B. Leslie
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  10. Judith Korner
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Corresponding author

Correspondence to Avis J. Thomas.

Additional information

This study was supported by a research grant from Covidien.

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Thomas, A.J., Bainbridge, H.A., Schone, J.L. et al. Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes. OBES SURG 24, 1875–1880 (2014). https://doi.org/10.1007/s11695-014-1280-4

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  • DOI: https://doi.org/10.1007/s11695-014-1280-4

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