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 D. Jensen; Daniel B. Leslie; Judith Korner

doi:10.1007/s11695-014-1280-4

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 D. Jensen, Daniel B. Leslie, Judith Korner

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

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 language	English (US)
Pages (from-to)	1875-1880
Number of pages	6
Journal	Obesity Surgery
Volume	24
Issue number	11
DOIs	https://doi.org/10.1007/s11695-014-1280-4
State	Published - Oct 11 2014

Bibliographical note

Funding Information:
This study was supported by a research grant from Covidien.

Funding Information:
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.

Publisher Copyright:
© 2014, Springer Science+Business Media New York.

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s11695-014-1280-4

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Thomas, A. J., Bainbridge, H. A., Schone, J. L., Chen, S. C., Connett, J. E., Ikramuddin, S., Lee, W. J., Jensen, M. D., Leslie, D. B., & 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, 24(11), 1875-1880. https://doi.org/10.1007/s11695-014-1280-4

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

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

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.",

keywords = "Bariatric surgery, Metabolic surgery, Randomized clinical trial, Recruitment, Roux-en-Y gastric bypass, Type 2 diabetes mellitus",

author = "Thomas, {Avis J.} and Bainbridge, {Heather A.} and Schone, {Joyce L.} and Chen, {Shu Chun} and Connett, {John E.} and Sayeed Ikramuddin and Lee, {Wei Jei} and Jensen, {Michael D.} and Leslie, {Daniel B.} and Judith Korner",

note = "Funding Information: This study was supported by a research grant from Covidien. Funding Information: 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. Publisher Copyright: {\textcopyright} 2014, Springer Science+Business Media New York.",

year = "2014",

month = oct,

day = "11",

doi = "10.1007/s11695-014-1280-4",

language = "English (US)",

volume = "24",

pages = "1875--1880",

journal = "Obesity Surgery",

issn = "0960-8923",

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TY - JOUR

T1 - Recruitment and Screening for a Randomized Trial Investigating Roux-en-Y Gastric Bypass versus Intensive Medical Management for Treatment of Type 2 Diabetes

AU - Thomas, Avis J.

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 D.

AU - Leslie, Daniel B.

AU - Korner, Judith

N1 - Funding Information: This study was supported by a research grant from Covidien. Funding Information: 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. Publisher Copyright: © 2014, Springer Science+Business Media New York.

PY - 2014/10/11

Y1 - 2014/10/11

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.

KW - Bariatric surgery

KW - Metabolic surgery

KW - Randomized clinical trial

KW - Recruitment

KW - Roux-en-Y gastric bypass

KW - Type 2 diabetes mellitus

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JO - Obesity Surgery

JF - Obesity Surgery

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ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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