Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes

A secondary analysis of the Look AHEAD randomised clinical trial

The Look AHEAD Research Group

Research output: Contribution to journalArticle

97 Citations (Scopus)

Abstract

Background: Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes. Methods: Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953. Findings: Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events. Interpretation: Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.

Original languageEnglish (US)
Pages (from-to)801-809
Number of pages9
JournalThe Lancet Diabetes and Endocrinology
Volume2
Issue number10
DOIs
StatePublished - Jan 1 2014

Fingerprint

Type 2 Diabetes Mellitus
Life Style
Weight Loss
Randomized Controlled Trials
Chronic Renal Insufficiency
Health
Education
Blood Pressure
Albuminuria
Incidence
Kidney Diseases
Diabetes Complications
Glomerular Filtration Rate
Proportional Hazards Models
Information Systems
Cardiovascular Diseases
Exercise
Kidney
Safety
Therapeutics

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{701f8f10d76547fbaafdc020912000f1,
title = "Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: A secondary analysis of the Look AHEAD randomised clinical trial",
abstract = "Background: Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes. Methods: Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953. Findings: Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94{\%}) of patients in the ILI group and 2408 (94{\%}) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95{\%} CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events. Interpretation: Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.",
author = "{The Look AHEAD Research Group} and Bahnson, {Judy L.} and Knowler, {W. C.} and Bantle, {J. P.} and Bertoni, {A. G.} and Bray, {G. A.} and H. Chen and L. Cheskin and Clark, {J. M.} and C. Egan and M. Evans and Foreyt, {J. P.} and Glasser, {S. P.} and Greenway, {F. L.} and Gregg, {E. W.} and Hazuda, {H. P.} and Hill, {J. O.} and Horton, {E. S.} and Hubbard, {V. S.} and Jakicic, {J. M.} and Jeffery, {R. W.} and Johnson, {K. C.} and Kahn, {S. E.} and Kitabchi, {A. E.} and Karen Johnson and J. Krakoff and A. Kure and Lewis, {C. E.} and Maschak-Carey, {B. J.} and S. Michaels and Montez, {M. G.} and Nathan, {D. M.} and E. Nyenwe and J. Patricio and A. Peters and Ebenezer Nyenwe and H. Pownall and Wadden, {T. A.} and Wagenknecht, {L. E.} and Williamson, {D. F.} and Wing, {R. R.} and H. Wyatt and Yanovski, {S. Z.}",
year = "2014",
month = "1",
day = "1",
doi = "10.1016/S2213-8587(14)70156-1",
language = "English (US)",
volume = "2",
pages = "801--809",
journal = "The Lancet Diabetes and Endocrinology",
issn = "2213-8587",
publisher = "Elsevier BV",
number = "10",

}

TY - JOUR

T1 - Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes

T2 - A secondary analysis of the Look AHEAD randomised clinical trial

AU - The Look AHEAD Research Group

AU - Bahnson, Judy L.

AU - Knowler, W. C.

AU - Bantle, J. P.

AU - Bertoni, A. G.

AU - Bray, G. A.

AU - Chen, H.

AU - Cheskin, L.

AU - Clark, J. M.

AU - Egan, C.

AU - Evans, M.

AU - Foreyt, J. P.

AU - Glasser, S. P.

AU - Greenway, F. L.

AU - Gregg, E. W.

AU - Hazuda, H. P.

AU - Hill, J. O.

AU - Horton, E. S.

AU - Hubbard, V. S.

AU - Jakicic, J. M.

AU - Jeffery, R. W.

AU - Johnson, K. C.

AU - Kahn, S. E.

AU - Kitabchi, A. E.

AU - Johnson, Karen

AU - Krakoff, J.

AU - Kure, A.

AU - Lewis, C. E.

AU - Maschak-Carey, B. J.

AU - Michaels, S.

AU - Montez, M. G.

AU - Nathan, D. M.

AU - Nyenwe, E.

AU - Patricio, J.

AU - Peters, A.

AU - Nyenwe, Ebenezer

AU - Pownall, H.

AU - Wadden, T. A.

AU - Wagenknecht, L. E.

AU - Williamson, D. F.

AU - Wing, R. R.

AU - Wyatt, H.

AU - Yanovski, S. Z.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background: Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes. Methods: Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953. Findings: Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events. Interpretation: Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.

AB - Background: Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes. Methods: Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953. Findings: Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events. Interpretation: Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.

UR - http://www.scopus.com/inward/record.url?scp=84921437510&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84921437510&partnerID=8YFLogxK

U2 - 10.1016/S2213-8587(14)70156-1

DO - 10.1016/S2213-8587(14)70156-1

M3 - Article

VL - 2

SP - 801

EP - 809

JO - The Lancet Diabetes and Endocrinology

JF - The Lancet Diabetes and Endocrinology

SN - 2213-8587

IS - 10

ER -