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Plasma Copeptin and Risk of Lower-Extremity Amputation In 2290 Diabetes Care Volume 42, December 2019 Plasma Copeptin and Risk of Louis Potier,1,2,3 Ronan Roussel,1,2,3 Michel Marre,1,2,3,4 Petter Bjornstad,4 Lower-Extremity Amputation in David Z. Cherney,5 Ray El Boustany,1,3 Fred´ eric´ Fumeron,2,3 Nicolas Venteclef,3 Type 1 and Type 2 Diabetes Jean-François Gautier,2,3,6 Samy Hadjadj,7 Kamel Mohammedi,8,9,10 and 3 Diabetes Care 2019;42:2290–2297 | https://doi.org/10.2337/dc19-1062 Gilberto Velho OBJECTIVE Diabetes is the leading cause of nontraumatic lower-extremity amputations (LEAs). Identification of patients with foot ulcers at risk for amputation remains clinically challenging. Plasma copeptin, a surrogate marker of vasopressin, is associated with the risk of cardiovascular and renal complications in diabetes. RESEARCH DESIGN AND METHODS We assessed the association between baseline plasma copeptin and risk of LEA 1Department of Diabetology, Endocrinology and during follow-up in four cohorts of people with type 1 (GENESIS, n 5 503, and Nutrition, DHU FIRE, Bichat Hospital, Assistance GENEDIAB, n 5 207) or type 2 diabetes (DIABHYCAR, n 5 3,101, and SURDIAGENE, Publique – Hopitauxˆ de Paris, Paris, France 2 n 5 1,452) with a median duration of follow-up between 5 and 10 years. Copeptin Universite´ de Paris, Paris, France 3INSERM, UMRS 1138, Cordeliers Research Cen- concentration was measured in baseline plasma samples by an immunolumino- ter, Paris, France metric assay. 4Section of Endocrinology, Department of Pedi- atrics,and DivisionofNephrology,Departmentof RESULTS Medicine, University of Colorado School of Med- Inthepooledcohorts with type1diabetes(n5 710),thecumulativeincidenceof LEA icine, Aurora, CO 5Division of Nephrology, Department of Medi- during follow-up by increasing tertiles (tertile 1 [TER1], TER2, and TER3) of baseline cine, Toronto General Hospital, University of plasma copeptin was 3.9% (TER1), 3.3% (TER2), and 10.0% (TER3) (P 5 0.002). Cox Toronto, Toronto, Ontario, Canada regression analyses confirmed the association of copeptin with LEA: hazard ratio 6Department of Diabetes, Clinical Investigation ` (HR) for 1 SD increment of log[copeptin] was 1.89 (95% CI 1.28–2.82), P 5 0.002. In Centre (CIC-9504), Lariboisiere Hospital, Assis- tance Publique – Hopitauxˆ de Paris, Paris, France the pooled cohorts of type 2 diabetes (n 5 4,553), the cumulative incidence of LEA 7L’Institut du thorax, INSERM, CNRS, Universite´ was 1.1% (TER1), 2.9% (TER2), and 3.6% (TER3) (P < 0.0001). In Cox regression de Nantes, Centre Hospitalier Universitaire de fi Nantes, Nantes, France PATHOPHYSIOLOGY/COMPLICATIONS analyses, baseline plasma copeptin was signi cantly associated with LEA: HR for 8 – P5 Department of Diabetology, Endocrinology and 1SDincrementof log[copeptin] was 1.42(1.15 1.74), 0.001.Similar results were Nutrition, Hopitalˆ Haut-Lev´ eque,ˆ Bordeaux, observed in the cohort with type 2 diabetes for lower-limb revascularization (HR France 1.20 [95% CI 1.03–1.39], P 5 0.02). 9Bordeaux University, Bordeaux, France 10INSERM U1219 “Bordeaux Population Health,” CONCLUSIONS Bordeaux, France Baseline plasma copeptin is associated with cumulative incidence of LEA in cohorts Corresponding author: Louis Potier, louis.potier of people with both type 1 and type 2 diabetes and may help to identify patients at @gmail.com risk for LEA. Received 27 May 2019 and accepted 10 September 2019 This article contains Supplementary Data online Diabetes is the leading cause of nontraumatic lower-extremity amputations (LEAs). at http://care.diabetesjournals.org/lookup/suppl/ LEA is a major complication of diabetes and is associated with low quality of life and doi:10.2337/dc19-1062/-/DC1. higher risk of mortality (1). The high prevalence of LEA in people with diabetes is mainly © 2019 by the American Diabetes Association. related to the presence of foot ulcers, and this complication is driven by a range of Readers may use this article as long as the work is properly cited, the use is educational and not factors including peripheral arterial disease (PAD), diabetic neuropathy, impaired for profit, and the work is not altered. More wound healing, and susceptibility to infection (2). However, despite these well-known information is available at http://www.diabetes causal factors, biomarkers able to predict the risk of LEA are lacking. We have recently journals.org/content/license. care.diabetesjournals.org Potier and Associates 2291 reported in a prospective cohort of peo- end point was reached or until February Comites´ de Protection des Personnes (CPP) ple with type 2 diabetes that the use of 2007. The subsets were composed of Ouest III, Poitiers, France (SURDIAGENE). diuretics was associated with a higher participants who attended outpatient risk of amputation (3). That work was clinics at least once during the follow-up Definition of Clinical Parameters and driven by the assumption that diuretic- period. Median duration of follow-up was Outcomes induced hypovolemia would worsen hy- 10.2 years (interquartile range 2.7) and In both type 1 and type 2 diabetes poperfusion of distal lower extremities, 5.0 years (1.6) for GENEDIAB and GENESIS, cohorts, an ad hoc event committee triggering ischemia and necrosis, even- respectively. In the present investigation, reviewed the case record of each patient tually leading to amputation. we studied 207 GENEDIAB and 503 to validate the baseline data and, later, More recent work has identified co- GENESIS participants for whom plasma the incidence of outcomes during peptin as a marker of circulating volume copeptin at baseline and LEA information follow-up (10,11). Estimated glomerular status. Copeptin is the COOH-terminal during follow-up were available. Study filtration rate (eGFR) was calculated us- portion of the preprovasopressin pep- protocols were approved by the ethics ing the CKD-EPI (Chronic Kidney Dis- tide and is cosecreted into the blood by committee of the Angers University Hos- ease Epidemiology Collaboration) study the neurohypophysis in an equimolar pital (Angers, France), and all participants equation for serum creatinine (14). Mi- amount with vasopressin. The main stim- gave written informed consent. croalbuminuria was defined as UAC uli for the secretion of vasopressin are an 30–300 mg/24 h, 20–200 mg/min, or Cohorts With Type 2 Diabetes increase in plasma osmolality and/or a 20–200 mg/L and macroalbuminuria as decrease in arterial circulating volume. DIABHYCAR was a multinational, multi- UAC .300 mg/24 h, .200 mg/min, or .200 Plasma copeptin has been involved in a centric clinical trial conducted in people mg/L. The primary outcome was the first wide range of pathophysiological pro- with type 2 diabetes selected on the basis occurrence of LEA during follow-up, as cesses, especially in patients with dia- of persistent microalbuminuria (urinary defined as a nontraumatic amputation at – betes, including the development and albumin concentration [UAC] 20 200 or above the metatarsophalangeal joint. progression of diabetic kidney disease mg/L) or macroalbuminuria (UAC 200 The requirement of lower-extremity re- and cardiovascular morbidity and mor- mg/L) without renal failure (plasma cre- vascularization (angioplasty or bypass sur- , m tality (4–9). atinine 150 mol/L) at baseline. The gery) during follow-up was considered a In line with this hypothesis, in the trial tested the effect of a low dose of secondary outcome for sensitivity analy- present investigation, we assessed the ramipril, an ACE inhibitor, on the inci- ses (data available only in the cohorts with relationship between copeptin, a surro- dence of cardiovascular and/or renal type 2 diabetes). History of diabetic foot gate of vasopressin and therefore hy- events. The median duration of follow-up ulcer at baseline and incident dia- dration status and LEA in people with was 5 years. Results were negative re- betic foot ulcer during follow-up was not diabetes. Specifically, in this analysis, garding the drug effect and have pre- reported in any of the cohorts. we assessed the association between viously were published (12). SURDIAGENE plasma copeptin at baseline with the is an ongoing prospective monocentric Laboratory Procedures risk of subsequent LEA in independent study aiming to identify the genetic and Copeptin concentration was measured in cohorts with type 1 and type 2 diabetes. environmental determinants of vascular fasting plasma–EDTA samples, collected complications in type 2 diabetes (13). at baseline and kept frozen at 280°C. RESEARCH DESIGN AND METHODS Patients have been recruited and followed Copeptin measurements were performed Study Population regularly since 2002 at the Diabetes De- by Thermo Fisher Scientific using their Cohorts With Type 1 Diabetes partment of the University Hospital of automated immunoluminometric assay Gen´ etiquedelaN´ ephropathie´ Diabetique´ Poitiers, France. Living status and cardio- (ultrasensitive Copeptin proAVP; Thermo (GENEDIAB) and Genesis France-Belgium vascular and kidney end points were de- Fisher Scientific, Hennigsdorf, Germany) (GENESIS) are two multicenter binational termined from patients’ hospital records (15). The limit of detection was 0.9 pmol/L. cohorts of people with long-standing and interviews with general practitioners Intra-assay coefficient of variation re- type 1 diabetes designed to study and recorded every other year since 2007. ported by the manufacturer was ,15% the vascular complications of diabetes. Median duration of follow-up was 7 years. and ,8% for concentration ranges of 2.0– GENEDIAB participants were selected on A detailed description of study popula- 4.0 pmol/L and 4.0–15.0 pmol/L, respec- the basis of a diagnosis of type 1 diabetes tion, outcome criteria, and adjudication tively. Interassay coefficient of variation before the age of 35 years and past or procedure was previously published for was ,18% and ,10%, respectively, for present diagnosis of severe diabetic ret- both cohorts (12). In the present inves- the lower and higher copeptin concen- inopathy (10). GENESIS was a family- tigation, we studied 3,101 and 1,452 tration range.
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