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

Avis J. Thomas, Heather A. Bainbridge, Joyce L. Schone, Shu Chun Chen, John E. Connett, Sayeed Ikramuddin, Wei Jei Lee, Michael Dennis Jensen, Daniel B. Leslie, Judith Korner

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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.

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.

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/m2and 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.

Original languageEnglish (US)
Pages (from-to)1875-1880
Number of pages6
JournalObesity Surgery
Volume24
Issue number11
DOIs
StatePublished - Oct 11 2014

Fingerprint

Gastric Bypass
Type 2 Diabetes Mellitus
Postal Service
Random Allocation
Body Mass Index
Randomized Controlled Trials
Physicians
Mass Media
Patient Preference
Glycosylated Hemoglobin A
Taiwan
Hyperglycemia
Life Style
Cardiovascular Diseases
Therapeutics
Referral and Consultation
Obesity
Databases

Keywords

  • Bariatric surgery
  • Metabolic surgery
  • Randomized clinical trial
  • Recruitment
  • Roux-en-Y gastric bypass
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

Cite this

Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes. / Thomas, Avis J.; Bainbridge, Heather A.; Schone, Joyce L.; Chen, Shu Chun; Connett, John E.; Ikramuddin, Sayeed; Lee, Wei Jei; Jensen, Michael Dennis; Leslie, Daniel B.; Korner, Judith.

In: Obesity Surgery, Vol. 24, No. 11, 11.10.2014, p. 1875-1880.

Research output: Contribution to journalArticle

Thomas, AJ, Bainbridge, HA, Schone, JL, Chen, SC, Connett, JE, Ikramuddin, S, Lee, WJ, Jensen, MD, Leslie, DB & Korner, J 2014, 'Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes', Obesity Surgery, vol. 24, no. 11, pp. 1875-1880. https://doi.org/10.1007/s11695-014-1280-4
Thomas, Avis J. ; Bainbridge, Heather A. ; Schone, Joyce L. ; Chen, Shu Chun ; Connett, John E. ; Ikramuddin, Sayeed ; Lee, Wei Jei ; Jensen, Michael Dennis ; Leslie, Daniel B. ; Korner, Judith. / Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes. In: Obesity Surgery. 2014 ; Vol. 24, No. 11. pp. 1875-1880.
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abstract = "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.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.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/m2and 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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AU - Bainbridge, Heather A.

AU - Schone, Joyce L.

AU - Chen, Shu Chun

AU - Connett, John E.

AU - Ikramuddin, Sayeed

AU - Lee, Wei Jei

AU - Jensen, Michael Dennis

AU - Leslie, Daniel B.

AU - Korner, Judith

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N2 - 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.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.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/m2and 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.

AB - 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.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.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/m2and 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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