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Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial

INTRODUCTION: This study of adults with type 2 diabetes employed a non-inferiority hypothesis to investigate whether an innovative lifestyle focused on minimizing postnutrient blood glucose (BG) excursions (glycemic excursion minimization (GEM)) would be equivalent or superior to conventional weight...

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Autores principales: Cox, Daniel J, Banton, Tom, Moncrief, Matthew, Conaway, Mark, Diamond, Anne, Holmes, Viola, Green Pastors, Joyce, Wolf, Anne, Fang, Kun, McCall, Anthony
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745682/
https://www.ncbi.nlm.nih.gov/pubmed/33328160
http://dx.doi.org/10.1136/bmjdrc-2020-001795
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author Cox, Daniel J
Banton, Tom
Moncrief, Matthew
Conaway, Mark
Diamond, Anne
Holmes, Viola
Green Pastors, Joyce
Wolf, Anne
Fang, Kun
McCall, Anthony
author_facet Cox, Daniel J
Banton, Tom
Moncrief, Matthew
Conaway, Mark
Diamond, Anne
Holmes, Viola
Green Pastors, Joyce
Wolf, Anne
Fang, Kun
McCall, Anthony
author_sort Cox, Daniel J
collection PubMed
description INTRODUCTION: This study of adults with type 2 diabetes employed a non-inferiority hypothesis to investigate whether an innovative lifestyle focused on minimizing postnutrient blood glucose (BG) excursions (glycemic excursion minimization (GEM)) would be equivalent or superior to conventional weight loss (WL) therapy in regard to reducing HbA1c, and superior to WL when investigating physical, behavioral and psychological secondary outcomes. The impact of BG feedback on GEM efficacy was also investigated. RESEARCH DESIGN AND METHODS: 178 adults with type 2 diabetes for ≤10 years, HbA1c ≥6.8%, and not using insulin were randomized to WL (n=40) or one of three versions of GEM. Didactic (GEM-D, n=39) taught participants to choose low-glycemic load foods, reduce sedentary time and increase moderate routine physical activity. GEM-S (n=51) received GEM-D and systematically measured BG before and after meals and physical activity to educate and motivate food and activity choices. GEM-C (n=48) received GEM-D with continuous glucose monitoring feedback. All participants received 6 hours of group training and BG and activity monitors. Before and 3 months after treatment, participants were assessed for HbA1c, lipids, weight, routine physical activity, nutrition, depression, diabetes empowerment and distress. RESULTS: GEM versions did not differ in primary or secondary outcomes, so they were combined for analyses. While WL reduced body mass index (BMI) (p=0.005), GEM demonstrated a greater reduction in HbA1c (p=0.005), BMI (p=0.013), carbohydrate intake (p=0.001), BG response to a glucose challenge (p=0.02), and cardiovascular risk (p=0.003). Only GEM participants significantly improved diabetes empowerment, diabetes distress, depressive symptoms, steps/day, and active hours and reduced calories/day. Neither intervention had negative side effects. CONCLUSIONS: GEM is an effective alternative to WL with respect to physical, behavioral and psychosocial outcomes. TRIAL REGISTRATION NUMBER: NCT03196895.
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spelling pubmed-77456822020-12-28 Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial Cox, Daniel J Banton, Tom Moncrief, Matthew Conaway, Mark Diamond, Anne Holmes, Viola Green Pastors, Joyce Wolf, Anne Fang, Kun McCall, Anthony BMJ Open Diabetes Res Care Clinical care/Education/Nutrition INTRODUCTION: This study of adults with type 2 diabetes employed a non-inferiority hypothesis to investigate whether an innovative lifestyle focused on minimizing postnutrient blood glucose (BG) excursions (glycemic excursion minimization (GEM)) would be equivalent or superior to conventional weight loss (WL) therapy in regard to reducing HbA1c, and superior to WL when investigating physical, behavioral and psychological secondary outcomes. The impact of BG feedback on GEM efficacy was also investigated. RESEARCH DESIGN AND METHODS: 178 adults with type 2 diabetes for ≤10 years, HbA1c ≥6.8%, and not using insulin were randomized to WL (n=40) or one of three versions of GEM. Didactic (GEM-D, n=39) taught participants to choose low-glycemic load foods, reduce sedentary time and increase moderate routine physical activity. GEM-S (n=51) received GEM-D and systematically measured BG before and after meals and physical activity to educate and motivate food and activity choices. GEM-C (n=48) received GEM-D with continuous glucose monitoring feedback. All participants received 6 hours of group training and BG and activity monitors. Before and 3 months after treatment, participants were assessed for HbA1c, lipids, weight, routine physical activity, nutrition, depression, diabetes empowerment and distress. RESULTS: GEM versions did not differ in primary or secondary outcomes, so they were combined for analyses. While WL reduced body mass index (BMI) (p=0.005), GEM demonstrated a greater reduction in HbA1c (p=0.005), BMI (p=0.013), carbohydrate intake (p=0.001), BG response to a glucose challenge (p=0.02), and cardiovascular risk (p=0.003). Only GEM participants significantly improved diabetes empowerment, diabetes distress, depressive symptoms, steps/day, and active hours and reduced calories/day. Neither intervention had negative side effects. CONCLUSIONS: GEM is an effective alternative to WL with respect to physical, behavioral and psychosocial outcomes. TRIAL REGISTRATION NUMBER: NCT03196895. BMJ Publishing Group 2020-12-16 /pmc/articles/PMC7745682/ /pubmed/33328160 http://dx.doi.org/10.1136/bmjdrc-2020-001795 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Clinical care/Education/Nutrition
Cox, Daniel J
Banton, Tom
Moncrief, Matthew
Conaway, Mark
Diamond, Anne
Holmes, Viola
Green Pastors, Joyce
Wolf, Anne
Fang, Kun
McCall, Anthony
Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title_full Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title_fullStr Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title_full_unstemmed Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title_short Glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
title_sort glycemic excursion minimization in the management of type 2 diabetes: a novel intervention tested in a randomized clinical trial
topic Clinical care/Education/Nutrition
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745682/
https://www.ncbi.nlm.nih.gov/pubmed/33328160
http://dx.doi.org/10.1136/bmjdrc-2020-001795
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