A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

Abstract Sodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGL...

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Autores principales: Yasuhiro Watanabe, Daisuke Suzuki, Nobuichi Kuribayashi, Daigaku Uchida, Mitsutoshi Kato, Hiroshi Ohashi, Daiji Nagayama, Takashi Yamaguchi, Masahiro Ohira, Atsuhito Saiki, Ichiro Tatsuno
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spelling oai:doaj.org-article:5793f965b8194c63ae146dc8b9d834052021-12-02T17:51:06ZA randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin10.1038/s41598-021-90879-z2045-2322https://doaj.org/article/5793f965b8194c63ae146dc8b9d834052021-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-90879-zhttps://doaj.org/toc/2045-2322Abstract Sodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGLT2i-treated T2DM patients remains unclear. We conducted a multicenter, double-blind, randomized, controlled, investigator-initiated clinical trial. 130 T2DM patients treated with dapagliflozin (5 mg) were randomized to isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD) (1:1 allocation) to replace one of three meals/day for 24 weeks. Primary outcome was change in HbA1c. Secondary outcomes were changes in serum insulin, body composition and other metabolic parameters. Although HbA1c decreased significantly in both groups [mean (95% confidence interval) − 0.7% (− 0.9 to − 0.5) in P-FD, − 0.6% (− 0.8 to − 0.5) in F-FD], change in HbA1c was not significantly different between the two groups (P = 0.4474). Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05). In T2DM treated with dapagliflozin, protein-enriched diet does not contribute to HbA1c reduction, although it decreases serum insulin and body fat mass, and increases HDL-cholesterol compared with fat-enriched diet with identical calories and carbohydrate ratio.Yasuhiro WatanabeDaisuke SuzukiNobuichi KuribayashiDaigaku UchidaMitsutoshi KatoHiroshi OhashiDaiji NagayamaTakashi YamaguchiMasahiro OhiraAtsuhito SaikiIchiro TatsunoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Yasuhiro Watanabe
Daisuke Suzuki
Nobuichi Kuribayashi
Daigaku Uchida
Mitsutoshi Kato
Hiroshi Ohashi
Daiji Nagayama
Takashi Yamaguchi
Masahiro Ohira
Atsuhito Saiki
Ichiro Tatsuno
A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
description Abstract Sodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGLT2i-treated T2DM patients remains unclear. We conducted a multicenter, double-blind, randomized, controlled, investigator-initiated clinical trial. 130 T2DM patients treated with dapagliflozin (5 mg) were randomized to isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD) (1:1 allocation) to replace one of three meals/day for 24 weeks. Primary outcome was change in HbA1c. Secondary outcomes were changes in serum insulin, body composition and other metabolic parameters. Although HbA1c decreased significantly in both groups [mean (95% confidence interval) − 0.7% (− 0.9 to − 0.5) in P-FD, − 0.6% (− 0.8 to − 0.5) in F-FD], change in HbA1c was not significantly different between the two groups (P = 0.4474). Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05). In T2DM treated with dapagliflozin, protein-enriched diet does not contribute to HbA1c reduction, although it decreases serum insulin and body fat mass, and increases HDL-cholesterol compared with fat-enriched diet with identical calories and carbohydrate ratio.
format article
author Yasuhiro Watanabe
Daisuke Suzuki
Nobuichi Kuribayashi
Daigaku Uchida
Mitsutoshi Kato
Hiroshi Ohashi
Daiji Nagayama
Takashi Yamaguchi
Masahiro Ohira
Atsuhito Saiki
Ichiro Tatsuno
author_facet Yasuhiro Watanabe
Daisuke Suzuki
Nobuichi Kuribayashi
Daigaku Uchida
Mitsutoshi Kato
Hiroshi Ohashi
Daiji Nagayama
Takashi Yamaguchi
Masahiro Ohira
Atsuhito Saiki
Ichiro Tatsuno
author_sort Yasuhiro Watanabe
title A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
title_short A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
title_full A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
title_fullStr A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
title_full_unstemmed A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
title_sort randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/5793f965b8194c63ae146dc8b9d83405
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