Dietary Management of Blood Glucose in Medical Critically Ill Overweight and Obese Patients: An Open-Label Randomized Trial.


Journal

JPEN. Journal of parenteral and enteral nutrition
ISSN: 1941-2444
Titre abrégé: JPEN J Parenter Enteral Nutr
Pays: United States
ID NLM: 7804134

Informations de publication

Date de publication:
05 2019
Historique:
received: 18 04 2018
revised: 03 08 2018
accepted: 16 08 2018
pubmed: 28 9 2018
medline: 12 9 2020
entrez: 28 9 2018
Statut: ppublish

Résumé

Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol. This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula. A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53). A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.

Sections du résumé

BACKGROUND
Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol.
METHODS
This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula.
RESULTS
A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53).
CONCLUSIONS
A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.

Identifiants

pubmed: 30260488
doi: 10.1002/jpen.1447
pmc: PMC7379263
doi:

Substances chimiques

Blood Glucose 0
Dietary Carbohydrates 0
Dietary Proteins 0
Insulin 0

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

471-480

Subventions

Organisme : Nestlé Health Science
Pays : International

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2018 Nestle Health Science. Journal of Parenteral and Enteral Nutrition published by Wiley Periodicals, Inc. on behalf of American Society for Parenteral and Enteral Nutrition.

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Auteurs

Todd W Rice (TW)

Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

D Clark Files (DC)

Department of Internal Medicine-Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Peter E Morris (PE)

University of Kentucky Healthcare, Lexington, Kentucky, USA.

Andrew C Bernard (AC)

University of Kentucky Healthcare, Lexington, Kentucky, USA.

Thomas R Ziegler (TR)

Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, Georgia, USA.

John W Drover (JW)

Department of Critical Care Medicine, Queen's University and Kingston Health Science Center, Kingston, Ontario, Canada.

John P Kress (JP)

The University of Chicago Medicine, Chicago, Illinois, USA.

Kealy R Ham (KR)

Department of Critical Care Medicine, Regions Hospital, University of Minnesota, St. Paul, Minnesota, USA.

Dominik J Grathwohl (DJ)

Nestlé Research Center, Vers-chez-les-Blanc, Lausanne, Switzerland.

Maureen B Huhmann (MB)

Nestlé Health Science, Bridgewater, New Jersey, USA.

Juan B Ochoa Gautier (JBO)

Nestlé Health Science, Bridgewater, New Jersey, USA.
Geisinger Medical Center, Danville, Pennsylvania, USA.

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