Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes.

Blood Glucose Blood Glucose Self-Monitoring Child Diabetes Mellitus, Type 1 Energy Intake Humans Sweetening Agents
Artificial sweeteners Diet soda Glycemic control Pediatrics Type 1 diabetes

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
07 2021
Historique:
received: 15 02 2021
revised: 15 04 2021
accepted: 05 05 2021
pubmed: 12 5 2021
medline: 25 9 2021
entrez: 11 5 2021
Statut: ppublish

Résumé

Low-calorie sweeteners (LCSs) provide sweetness without sugar or calories and are used to replace added sugars by many children with type 1 diabetes (T1D). However, the role of LCSs in diabetes management and cardiometabolic health is unclear. The Diabetes Research in Kids Study (DRINK-T1D) aims to investigate effects of LCS restriction on glycemic variability, visceral adiposity, lipid profiles, and systemic inflammation among children 6-12 years old with T1D. Children with T1D, who report habitual consumption of foods and beverages containing LCSs, are recruited from the Washington Nationals Diabetes Care Complex (DCC) at Children's National Hospital (CNH) in Washington, DC. Following a phone screening and two-week run-in period involving continuation of usual LCS intake, children are randomized to 12 weeks of LCS restriction (replacement of diet beverages with still or sparkling water and avoidance of other sources of LCSs) or continued usual LCS intake (control). The primary outcome is the difference in change in glycemic variability in the LCS restriction group versus the control group. Change in glycemic variability will be assessed as the difference in daily average time-in-range (TIR), measured using continuous glucose monitoring (CGM) during two weeks at the end of the 12-week intervention, compared with during the two-week run-in period prior to randomization. Participants also complete a variety of anthropometric, metabolic, dietary, and behavioral assessments throughout the 14-week study. DRINK-T1D is an innovative, randomized controlled trial, evaluating effects of LCS restriction on glycemic variability and cardiometabolic health in children with T1D. Findings of DRINK-T1D will support or challenge the common practice of recommending LCS use in this patient population and will have clinically relevant implications for pediatric T1D management. ClinicalTrials.gov Identifier NCT04385888.

Sections du résumé

BACKGROUND
Low-calorie sweeteners (LCSs) provide sweetness without sugar or calories and are used to replace added sugars by many children with type 1 diabetes (T1D). However, the role of LCSs in diabetes management and cardiometabolic health is unclear.
OBJECTIVE
The Diabetes Research in Kids Study (DRINK-T1D) aims to investigate effects of LCS restriction on glycemic variability, visceral adiposity, lipid profiles, and systemic inflammation among children 6-12 years old with T1D.
METHODS
Children with T1D, who report habitual consumption of foods and beverages containing LCSs, are recruited from the Washington Nationals Diabetes Care Complex (DCC) at Children's National Hospital (CNH) in Washington, DC. Following a phone screening and two-week run-in period involving continuation of usual LCS intake, children are randomized to 12 weeks of LCS restriction (replacement of diet beverages with still or sparkling water and avoidance of other sources of LCSs) or continued usual LCS intake (control). The primary outcome is the difference in change in glycemic variability in the LCS restriction group versus the control group. Change in glycemic variability will be assessed as the difference in daily average time-in-range (TIR), measured using continuous glucose monitoring (CGM) during two weeks at the end of the 12-week intervention, compared with during the two-week run-in period prior to randomization. Participants also complete a variety of anthropometric, metabolic, dietary, and behavioral assessments throughout the 14-week study.
CONCLUSIONS
DRINK-T1D is an innovative, randomized controlled trial, evaluating effects of LCS restriction on glycemic variability and cardiometabolic health in children with T1D. Findings of DRINK-T1D will support or challenge the common practice of recommending LCS use in this patient population and will have clinically relevant implications for pediatric T1D management.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT04385888.

Identifiants

DOI: 10.1016/j.cct.2021.106431 PMID: 33974993 PMC: PMC8222177
pubmed: 33974993
pii: S1551-7144(21)00167-1
doi: 10.1016/j.cct.2021.106431
pmc: PMC8222177
mid: NIHMS1705313
pii:
doi:

Substances chimiques

Blood Glucose 0
Sweetening Agents 0

Banques de données

ClinicalTrials.gov
['NCT04385888']

Types de publication

Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

106431

Subventions

Organisme : NIDDK NIH HHS
ID : R21 DK122345
Pays : United States

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Références

Epidemiology. 2013 Sep;24(5):773-4
pubmed: 23903880
Pediatr Clin North Am. 2011 Dec;58(6):1467-80, xi
pubmed: 22093863
Nutrients. 2018 Feb 10;10(2):
pubmed: 29439389
J Pediatr Health Care. 2018 May - Jun;32(3):231-235
pubmed: 29290409
Rev Endocr Metab Disord. 2016 Jun;17(2):179-86
pubmed: 27387506
CMAJ. 2017 Jul 17;189(28):E929-E939
pubmed: 28716847
Nutr Metab (Lond). 2016 Oct 21;13:71
pubmed: 27777606
Diabetologia. 2015 Jul;58(7):1474-83
pubmed: 25944371
Stem Cell Res Ther. 2020 Jun 26;11(1):250
pubmed: 32586409
J Clin Endocrinol Metab. 2010 Jun;95(6):2868-76
pubmed: 20371668
J Gen Intern Med. 2012 Sep;27(9):1120-6
pubmed: 22282311
Atherosclerosis. 2015 Jan;238(1):33-7
pubmed: 25437887
Trends Endocrinol Metab. 2013 Sep;24(9):431-41
pubmed: 23850261
Pediatrics. 2019 Nov;144(5):
pubmed: 31659005
J Pediatr Psychol. 2009 Oct;34(9):999-1007
pubmed: 19423660
J Acad Nutr Diet. 2017 Mar;117(3):441-448.e2
pubmed: 28087414
Acta Diabetol. 2011 Dec;48(4):275-282
pubmed: 21249401
Front Physiol. 2017 Jul 24;8:487
pubmed: 28790923
Am J Clin Nutr. 2018 Sep 1;108(3):485-491
pubmed: 30535090
Stroke. 2017 May;48(5):1139-1146
pubmed: 28428346
Diabetes Care. 2009 Apr;32(4):688-94
pubmed: 19151203
J Nutr. 2020 Jul 1;150(7):1773-1781
pubmed: 32321168
Lancet. 2018 Aug 11;392(10146):477-486
pubmed: 30129464
Nutrition. 2018 Nov;55-56:125-130
pubmed: 30005329
Front Microbiol. 2019 Jun 20;10:1360
pubmed: 31281295
Circulation. 2018 Aug 28;138(9):e126-e140
pubmed: 30354445
Br J Nutr. 2016 Jan 28;115(2):294-304
pubmed: 26525591
PLoS One. 2014 Oct 14;9(10):e109841
pubmed: 25313461
Circulation. 2008 Feb 12;117(6):754-61
pubmed: 18212291
Nature. 2014 Oct 9;514(7521):181-6
pubmed: 25231862
Mol Nutr Food Res. 2020 Jun;64(11):e1901166
pubmed: 32281732
Phys Ther. 2020 Aug 12;100(8):1393-1410
pubmed: 32313952
J Physiol. 2007 Jul 1;582(Pt 1):379-92
pubmed: 17495045
Diabetes Care. 2013 Sep;36(9):2530-5
pubmed: 23633524
Ther Adv Chronic Dis. 2015 Nov;6(6):347-74
pubmed: 26568811

Auteurs

Allison C Sylvetsky (AC)

Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA. Electronic address: asylvets@gwu.edu.

Hailey R Moore (HR)

Division of Psychology & Behavioral Health, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA.

Jasmine H Kaidbey (JH)

Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.

Sabrina E Halberg (SE)

Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.

Fran R Cogen (FR)

Division of Endocrinology, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA; School of Medicine and Health Sciences, The George Washington University, 2300 I St. NW, Washington, DC 20052, USA.

Loretta DiPietro (L)

Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.

Angelo Elmi (A)

Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Washington, DC 20052, USA.

Michael I Goran (MI)

Department of Pediatrics, The Saban Research Institute, Children's Hospital Los Angeles, 4650 Sunset Blvd, Los Angeles, CA 90027, USA.

Randi Streisand (R)

Division of Psychology & Behavioral Health, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA; School of Medicine and Health Sciences, The George Washington University, 2300 I St. NW, Washington, DC 20052, USA.

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Classifications MeSH

Recherchemedicale.com › Glucides › Sucres › Oses › Hexose › Glucose › Glycémie › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Techniques d'investigation › Techniques de laboratoire clinique › Tests de chimie clinique › Analyse chimique du sang › Autosurveillance glycémique › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Personnes › Tranches d'âge › Enfant › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Maladies du système immunitaire › Maladies auto-immunes › Diabète de type 1 › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Phénomènes physiologiques › Alimentation et nutrition › Phénomènes physiologiques nutritionnels › Régime alimentaire › Ration calorique › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Rationale and design of DRINK-T1D: A...
Recherchemedicale.com › Aliments et boissons › Aliments › Ingrédients alimentaires › Additifs alimentaires › Aromatisants › Édulcorants › Rationale and design of DRINK-T1D: A...