Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery

Ted D. Adams, Erick Avelar, Tom Cloward, Ross D. Crosby, Robert J. Farney, Richard Gress, R. Chad Halverson, Paul N. Hopkins, Ronette L. Kolotkin, Michael J. LaMonte, Sheldon Litwin, Robert T. Nuttall, Robert Pendleton, Wayne Rosamond, Steven C. Simper, Sherman C. Smith, Michael Strong, James M. Walker, Gail Wiebke, Frank G. Yanowitz & 1 others Steven Hunt

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Purpose: This paper details the design and baseline characteristics of a study on the morbidity associated with Roux-en-Y gastric bypass surgery (GBP) in severely obese adults. This study is designed to assess the effectiveness of GBP in reducing morbidity and maintaining weight loss. A wide array of clinical tests and psycho-behavioral questionnaires are included as part of the study. Methods: Three groups (n = 1156 severely obese) have been recruited for this study: cases who were approved for and participated in surgery (n = 415), a control group of GBP seeking individuals who were denied surgery (n = 420) and a control group that was randomly chosen from a population of severely obese participants who were not seeking GBP (n = 321). Clinical measures include: a physician interview and detailed medical history, resting electro- and echocardiograms, a submaximal exercise treadmill test and electrocardiogram, pulmonary function, limited polysomnography, resting metabolic rate, anthropometrics, resting and exercise blood pressure, comprehensive blood chemistry and urinalysis and dietary, quality of life and physical activity questionnaires. Most participants (76%) were tested following an overnight stay in a clinical research center. Remaining participants underwent less extensive testing in an outpatient clinic. Results: Baseline characteristics of the 1156 participants are available for selected measures. Mean ± S.D. for BMI was 46 ± 7.5 kg/m2 (range = 33 to 92) and for age was 44 ± 11.4 years (range = 18 to 72). The prevalence of diabetes and hypertension was 19% and 35%, respectively. Of the participants who had an echocardiogram or polysomnogram, 92% had left-ventricular hypertrophy and 85% had mild to severe sleep apnea. The two control groups were similar to the surgical group. At approximately 24 months, all participants will have a second clinical examination. Statistical comparisons of changes in morbidity variables will be made between the surgical and control groups. Conclusions: This study design facilitates assessment of risks and benefits of GBP to perform recommendations on whether or not to perform surgery on the severely obese patient. Baseline and 2-year exams provide valuable data for comparison to future long-term follow-up data that can be collected at 5 and 10 years.

Original languageEnglish
Pages (from-to)534-551
Number of pages18
JournalContemporary Clinical Trials
Volume26
Issue number5
DOIs
Publication statusPublished - Oct 2005
Externally publishedYes

Fingerprint

Gastric Bypass
Obesity
Morbidity
Control Groups
Exercise Test
Electrocardiography
Exercise
Basal Metabolism
Urinalysis
Polysomnography
Sleep Apnea Syndromes
Left Ventricular Hypertrophy
Ambulatory Care Facilities
Weight Loss
Quality of Life
Interviews
Blood Pressure
Hypertension
Physicians
Lung

Keywords

  • Dietary history
  • Echocardiogram
  • Exercise test
  • Gastric bypass surgery
  • IWQOL
  • Physical activity
  • Polysomnography
  • Pulmonary
  • Roux-en-Y
  • Sleep apnea

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery. / Adams, Ted D.; Avelar, Erick; Cloward, Tom; Crosby, Ross D.; Farney, Robert J.; Gress, Richard; Halverson, R. Chad; Hopkins, Paul N.; Kolotkin, Ronette L.; LaMonte, Michael J.; Litwin, Sheldon; Nuttall, Robert T.; Pendleton, Robert; Rosamond, Wayne; Simper, Steven C.; Smith, Sherman C.; Strong, Michael; Walker, James M.; Wiebke, Gail; Yanowitz, Frank G.; Hunt, Steven.

In: Contemporary Clinical Trials, Vol. 26, No. 5, 10.2005, p. 534-551.

Research output: Contribution to journalArticle

Adams, TD, Avelar, E, Cloward, T, Crosby, RD, Farney, RJ, Gress, R, Halverson, RC, Hopkins, PN, Kolotkin, RL, LaMonte, MJ, Litwin, S, Nuttall, RT, Pendleton, R, Rosamond, W, Simper, SC, Smith, SC, Strong, M, Walker, JM, Wiebke, G, Yanowitz, FG & Hunt, S 2005, 'Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery', Contemporary Clinical Trials, vol. 26, no. 5, pp. 534-551. https://doi.org/10.1016/j.cct.2005.05.003
Adams, Ted D. ; Avelar, Erick ; Cloward, Tom ; Crosby, Ross D. ; Farney, Robert J. ; Gress, Richard ; Halverson, R. Chad ; Hopkins, Paul N. ; Kolotkin, Ronette L. ; LaMonte, Michael J. ; Litwin, Sheldon ; Nuttall, Robert T. ; Pendleton, Robert ; Rosamond, Wayne ; Simper, Steven C. ; Smith, Sherman C. ; Strong, Michael ; Walker, James M. ; Wiebke, Gail ; Yanowitz, Frank G. ; Hunt, Steven. / Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery. In: Contemporary Clinical Trials. 2005 ; Vol. 26, No. 5. pp. 534-551.
@article{0f0ad18b003a43d19c66eb94dce8dc3b,
title = "Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery",
abstract = "Purpose: This paper details the design and baseline characteristics of a study on the morbidity associated with Roux-en-Y gastric bypass surgery (GBP) in severely obese adults. This study is designed to assess the effectiveness of GBP in reducing morbidity and maintaining weight loss. A wide array of clinical tests and psycho-behavioral questionnaires are included as part of the study. Methods: Three groups (n = 1156 severely obese) have been recruited for this study: cases who were approved for and participated in surgery (n = 415), a control group of GBP seeking individuals who were denied surgery (n = 420) and a control group that was randomly chosen from a population of severely obese participants who were not seeking GBP (n = 321). Clinical measures include: a physician interview and detailed medical history, resting electro- and echocardiograms, a submaximal exercise treadmill test and electrocardiogram, pulmonary function, limited polysomnography, resting metabolic rate, anthropometrics, resting and exercise blood pressure, comprehensive blood chemistry and urinalysis and dietary, quality of life and physical activity questionnaires. Most participants (76{\%}) were tested following an overnight stay in a clinical research center. Remaining participants underwent less extensive testing in an outpatient clinic. Results: Baseline characteristics of the 1156 participants are available for selected measures. Mean ± S.D. for BMI was 46 ± 7.5 kg/m2 (range = 33 to 92) and for age was 44 ± 11.4 years (range = 18 to 72). The prevalence of diabetes and hypertension was 19{\%} and 35{\%}, respectively. Of the participants who had an echocardiogram or polysomnogram, 92{\%} had left-ventricular hypertrophy and 85{\%} had mild to severe sleep apnea. The two control groups were similar to the surgical group. At approximately 24 months, all participants will have a second clinical examination. Statistical comparisons of changes in morbidity variables will be made between the surgical and control groups. Conclusions: This study design facilitates assessment of risks and benefits of GBP to perform recommendations on whether or not to perform surgery on the severely obese patient. Baseline and 2-year exams provide valuable data for comparison to future long-term follow-up data that can be collected at 5 and 10 years.",
keywords = "Dietary history, Echocardiogram, Exercise test, Gastric bypass surgery, IWQOL, Physical activity, Polysomnography, Pulmonary, Roux-en-Y, Sleep apnea",
author = "Adams, {Ted D.} and Erick Avelar and Tom Cloward and Crosby, {Ross D.} and Farney, {Robert J.} and Richard Gress and Halverson, {R. Chad} and Hopkins, {Paul N.} and Kolotkin, {Ronette L.} and LaMonte, {Michael J.} and Sheldon Litwin and Nuttall, {Robert T.} and Robert Pendleton and Wayne Rosamond and Simper, {Steven C.} and Smith, {Sherman C.} and Michael Strong and Walker, {James M.} and Gail Wiebke and Yanowitz, {Frank G.} and Steven Hunt",
year = "2005",
month = "10",
doi = "10.1016/j.cct.2005.05.003",
language = "English",
volume = "26",
pages = "534--551",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Design and rationale of the Utah obesity study. A study to assess morbidity following gastric bypass surgery

AU - Adams, Ted D.

AU - Avelar, Erick

AU - Cloward, Tom

AU - Crosby, Ross D.

AU - Farney, Robert J.

AU - Gress, Richard

AU - Halverson, R. Chad

AU - Hopkins, Paul N.

AU - Kolotkin, Ronette L.

AU - LaMonte, Michael J.

AU - Litwin, Sheldon

AU - Nuttall, Robert T.

AU - Pendleton, Robert

AU - Rosamond, Wayne

AU - Simper, Steven C.

AU - Smith, Sherman C.

AU - Strong, Michael

AU - Walker, James M.

AU - Wiebke, Gail

AU - Yanowitz, Frank G.

AU - Hunt, Steven

PY - 2005/10

Y1 - 2005/10

N2 - Purpose: This paper details the design and baseline characteristics of a study on the morbidity associated with Roux-en-Y gastric bypass surgery (GBP) in severely obese adults. This study is designed to assess the effectiveness of GBP in reducing morbidity and maintaining weight loss. A wide array of clinical tests and psycho-behavioral questionnaires are included as part of the study. Methods: Three groups (n = 1156 severely obese) have been recruited for this study: cases who were approved for and participated in surgery (n = 415), a control group of GBP seeking individuals who were denied surgery (n = 420) and a control group that was randomly chosen from a population of severely obese participants who were not seeking GBP (n = 321). Clinical measures include: a physician interview and detailed medical history, resting electro- and echocardiograms, a submaximal exercise treadmill test and electrocardiogram, pulmonary function, limited polysomnography, resting metabolic rate, anthropometrics, resting and exercise blood pressure, comprehensive blood chemistry and urinalysis and dietary, quality of life and physical activity questionnaires. Most participants (76%) were tested following an overnight stay in a clinical research center. Remaining participants underwent less extensive testing in an outpatient clinic. Results: Baseline characteristics of the 1156 participants are available for selected measures. Mean ± S.D. for BMI was 46 ± 7.5 kg/m2 (range = 33 to 92) and for age was 44 ± 11.4 years (range = 18 to 72). The prevalence of diabetes and hypertension was 19% and 35%, respectively. Of the participants who had an echocardiogram or polysomnogram, 92% had left-ventricular hypertrophy and 85% had mild to severe sleep apnea. The two control groups were similar to the surgical group. At approximately 24 months, all participants will have a second clinical examination. Statistical comparisons of changes in morbidity variables will be made between the surgical and control groups. Conclusions: This study design facilitates assessment of risks and benefits of GBP to perform recommendations on whether or not to perform surgery on the severely obese patient. Baseline and 2-year exams provide valuable data for comparison to future long-term follow-up data that can be collected at 5 and 10 years.

AB - Purpose: This paper details the design and baseline characteristics of a study on the morbidity associated with Roux-en-Y gastric bypass surgery (GBP) in severely obese adults. This study is designed to assess the effectiveness of GBP in reducing morbidity and maintaining weight loss. A wide array of clinical tests and psycho-behavioral questionnaires are included as part of the study. Methods: Three groups (n = 1156 severely obese) have been recruited for this study: cases who were approved for and participated in surgery (n = 415), a control group of GBP seeking individuals who were denied surgery (n = 420) and a control group that was randomly chosen from a population of severely obese participants who were not seeking GBP (n = 321). Clinical measures include: a physician interview and detailed medical history, resting electro- and echocardiograms, a submaximal exercise treadmill test and electrocardiogram, pulmonary function, limited polysomnography, resting metabolic rate, anthropometrics, resting and exercise blood pressure, comprehensive blood chemistry and urinalysis and dietary, quality of life and physical activity questionnaires. Most participants (76%) were tested following an overnight stay in a clinical research center. Remaining participants underwent less extensive testing in an outpatient clinic. Results: Baseline characteristics of the 1156 participants are available for selected measures. Mean ± S.D. for BMI was 46 ± 7.5 kg/m2 (range = 33 to 92) and for age was 44 ± 11.4 years (range = 18 to 72). The prevalence of diabetes and hypertension was 19% and 35%, respectively. Of the participants who had an echocardiogram or polysomnogram, 92% had left-ventricular hypertrophy and 85% had mild to severe sleep apnea. The two control groups were similar to the surgical group. At approximately 24 months, all participants will have a second clinical examination. Statistical comparisons of changes in morbidity variables will be made between the surgical and control groups. Conclusions: This study design facilitates assessment of risks and benefits of GBP to perform recommendations on whether or not to perform surgery on the severely obese patient. Baseline and 2-year exams provide valuable data for comparison to future long-term follow-up data that can be collected at 5 and 10 years.

KW - Dietary history

KW - Echocardiogram

KW - Exercise test

KW - Gastric bypass surgery

KW - IWQOL

KW - Physical activity

KW - Polysomnography

KW - Pulmonary

KW - Roux-en-Y

KW - Sleep apnea

UR - http://www.scopus.com/inward/record.url?scp=24144480975&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=24144480975&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2005.05.003

DO - 10.1016/j.cct.2005.05.003

M3 - Article

VL - 26

SP - 534

EP - 551

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 5

ER -