Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial

Eva M. Gram-Kampmann; Camilla D. Hansen; Mie B. Hugger; Jane M. Jensen; Jan C. Brønd; Anne Pernille Hermann; Aleksander Krag; Michael H. Olsen; Henning Beck-Nielsen; Kurt Højlund

doi:10.1111/dom.14633

Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial

Eva M. Gram-Kampmann, Camilla D. Hansen, Mie B. Hugger, Jane M. Jensen, Jan C. Brønd, Anne Pernille Hermann, Aleksander Krag, Michael H. Olsen, Henning Beck-Nielsen, Kurt Højlund^*

^*Kontaktforfatter

Steno Diabetes Center Sjælland

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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Abstract

Aim: To investigate the efficacy and safety of a non-calorie–restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity. Materials and Methods: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported. Results: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was −30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P <.001). The LCD reduced HbA1c after 3 months (−8.9 ± 1.7 mmol/mol; P <.0001), and this was maintained after 6 months (−7.5 ± 1.8 mmol/mol; P <.0001) compared with the control diet. The LCD also reduced weight (−3.9 ± 1.0 kg), body mass index (−1.4 ± 0.4 kg/m²), and waist circumference (−4.9 ± 1.3 cm) compared with the control diet (all P <.01), accompanied by reductions in total fat mass (−2.2 ± 1.0 kg; P =.027) and lean mass (−1.3 ± 0.6 kg; P =.017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia. Conclusion: A non-calorie–restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia.

Originalsprog	Engelsk
Tidsskrift	Diabetes, Obesity and Metabolism
Vol/bind	24
Udgave nummer	4
Sider (fra-til)	693-703
ISSN	1462-8902
DOI	https://doi.org/10.1111/dom.14633
Status	Udgivet - apr. 2022

Bibliografisk note

Funding Information:
We would like to thank L. Hansen and C. B. Olsen, the Steno Diabetes Center Odense, Odense University Hospital, as well as A. R. Madsen, Department of Endocrinology, Odense University Hospital, for their skilled technical assistance. We thank J. V. Stidsen at the Steno Diabetes Center Odense, Odense University Hospital, for statistical support. This study was supported by grants from the Region of Southern Denmark, Odense University Hospital, the Danish Diabetes Academy funded by the Novo Nordisk Foundation, the Novo Nordisk Foundation, University of Southern Denmark, AP Møller Foundation, and from Overlæge Johan Boserup og Lise Boserups Legat.

Funding Information:
AP Møller Foundation; Danish Diabetes Academy funded by the Novo Nordisk Foundation; Novo Nordisk Fonden; Odense Universitetshospital; Overlæge Johan Boserup og Lise Boserups Legat; Region of Southern Denmark; Syddansk Universitet Funding information

Publisher Copyright:
© 2022 John Wiley & Sons Ltd.

Dokumenter og links

10.1111/dom.14633

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1 Ph.d.-afhandling

A Low-Carbohydrate Diet in Type 2 Diabetes: Effects over six months on glycemic control, cardiovascular risk factors, vascular endothelial function and pro-inflammatory markers
Bidragets oversatte titel: Lavkulhydratdiæt og Type 2 Diabetes: Effekt over seks måneder på glykæmisk kontrol, kardiovaskulære risikofaktorer, vaskulær endotelfunktion og proinflammatoriske markørerGram-Kampmann, E., 27. apr. 2023, Syddansk Universitet. Det Sundhedsvidenskabelige Fakultet. 139 s.
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Gram-Kampmann, E. M., Hansen, C. D., Hugger, M. B., Jensen, J. M., Brønd, J. C., Hermann, A. P., Krag, A., Olsen, M. H., Beck-Nielsen, H., & Højlund, K. (2022). Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial. Diabetes, Obesity and Metabolism, 24(4), 693-703. https://doi.org/10.1111/dom.14633

@article{53dea18b2d2e4bb7bc62457c9851c77e,

title = "Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial",

abstract = "Aim: To investigate the efficacy and safety of a non-calorie–restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity. Materials and Methods: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported. Results: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was −30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P <.001). The LCD reduced HbA1c after 3 months (−8.9 ± 1.7 mmol/mol; P <.0001), and this was maintained after 6 months (−7.5 ± 1.8 mmol/mol; P <.0001) compared with the control diet. The LCD also reduced weight (−3.9 ± 1.0 kg), body mass index (−1.4 ± 0.4 kg/m2), and waist circumference (−4.9 ± 1.3 cm) compared with the control diet (all P <.01), accompanied by reductions in total fat mass (−2.2 ± 1.0 kg; P =.027) and lean mass (−1.3 ± 0.6 kg; P =.017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia. Conclusion: A non-calorie–restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia.",

keywords = "low-carbohydrate diet, non-calorie–restricted, physical activity, randomized controlled trial, type 2 diabetes",

author = "Gram-Kampmann, {Eva M.} and Hansen, {Camilla D.} and Hugger, {Mie B.} and Jensen, {Jane M.} and Br{\o}nd, {Jan C.} and Hermann, {Anne Pernille} and Aleksander Krag and Olsen, {Michael H.} and Henning Beck-Nielsen and Kurt H{\o}jlund",

note = "Funding Information: We would like to thank L. Hansen and C. B. Olsen, the Steno Diabetes Center Odense, Odense University Hospital, as well as A. R. Madsen, Department of Endocrinology, Odense University Hospital, for their skilled technical assistance. We thank J. V. Stidsen at the Steno Diabetes Center Odense, Odense University Hospital, for statistical support. This study was supported by grants from the Region of Southern Denmark, Odense University Hospital, the Danish Diabetes Academy funded by the Novo Nordisk Foundation, the Novo Nordisk Foundation, University of Southern Denmark, AP M{\o}ller Foundation, and from Overl{\ae}ge Johan Boserup og Lise Boserups Legat. Funding Information: AP M{\o}ller Foundation; Danish Diabetes Academy funded by the Novo Nordisk Foundation; Novo Nordisk Fonden; Odense Universitetshospital; Overl{\ae}ge Johan Boserup og Lise Boserups Legat; Region of Southern Denmark; Syddansk Universitet Funding information Publisher Copyright: {\textcopyright} 2022 John Wiley & Sons Ltd.",

year = "2022",

month = apr,

doi = "10.1111/dom.14633",

language = "English",

volume = "24",

pages = "693--703",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley",

number = "4",

}

Gram-Kampmann, EM, Hansen, CD, Hugger, MB, Jensen, JM , Brønd, JC , Hermann, AP , Krag, A , Olsen, MH, Beck-Nielsen, H & Højlund, K 2022, 'Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial', Diabetes, Obesity and Metabolism, bind 24, nr. 4, s. 693-703. https://doi.org/10.1111/dom.14633

Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial. / Gram-Kampmann, Eva M.; Hansen, Camilla D.; Hugger, Mie B. et al.
I: Diabetes, Obesity and Metabolism, Bind 24, Nr. 4, 04.2022, s. 693-703.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes

T2 - An open-label randomized controlled trial

AU - Gram-Kampmann, Eva M.

AU - Hansen, Camilla D.

AU - Hugger, Mie B.

AU - Jensen, Jane M.

AU - Brønd, Jan C.

AU - Hermann, Anne Pernille

AU - Krag, Aleksander

AU - Olsen, Michael H.

AU - Beck-Nielsen, Henning

AU - Højlund, Kurt

N1 - Funding Information: We would like to thank L. Hansen and C. B. Olsen, the Steno Diabetes Center Odense, Odense University Hospital, as well as A. R. Madsen, Department of Endocrinology, Odense University Hospital, for their skilled technical assistance. We thank J. V. Stidsen at the Steno Diabetes Center Odense, Odense University Hospital, for statistical support. This study was supported by grants from the Region of Southern Denmark, Odense University Hospital, the Danish Diabetes Academy funded by the Novo Nordisk Foundation, the Novo Nordisk Foundation, University of Southern Denmark, AP Møller Foundation, and from Overlæge Johan Boserup og Lise Boserups Legat. Funding Information: AP Møller Foundation; Danish Diabetes Academy funded by the Novo Nordisk Foundation; Novo Nordisk Fonden; Odense Universitetshospital; Overlæge Johan Boserup og Lise Boserups Legat; Region of Southern Denmark; Syddansk Universitet Funding information Publisher Copyright: © 2022 John Wiley & Sons Ltd.

PY - 2022/4

Y1 - 2022/4

N2 - Aim: To investigate the efficacy and safety of a non-calorie–restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity. Materials and Methods: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported. Results: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was −30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P <.001). The LCD reduced HbA1c after 3 months (−8.9 ± 1.7 mmol/mol; P <.0001), and this was maintained after 6 months (−7.5 ± 1.8 mmol/mol; P <.0001) compared with the control diet. The LCD also reduced weight (−3.9 ± 1.0 kg), body mass index (−1.4 ± 0.4 kg/m2), and waist circumference (−4.9 ± 1.3 cm) compared with the control diet (all P <.01), accompanied by reductions in total fat mass (−2.2 ± 1.0 kg; P =.027) and lean mass (−1.3 ± 0.6 kg; P =.017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia. Conclusion: A non-calorie–restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia.

AB - Aim: To investigate the efficacy and safety of a non-calorie–restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity. Materials and Methods: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported. Results: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was −30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P <.001). The LCD reduced HbA1c after 3 months (−8.9 ± 1.7 mmol/mol; P <.0001), and this was maintained after 6 months (−7.5 ± 1.8 mmol/mol; P <.0001) compared with the control diet. The LCD also reduced weight (−3.9 ± 1.0 kg), body mass index (−1.4 ± 0.4 kg/m2), and waist circumference (−4.9 ± 1.3 cm) compared with the control diet (all P <.01), accompanied by reductions in total fat mass (−2.2 ± 1.0 kg; P =.027) and lean mass (−1.3 ± 0.6 kg; P =.017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia. Conclusion: A non-calorie–restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia.

KW - low-carbohydrate diet

KW - non-calorie–restricted

KW - physical activity

KW - randomized controlled trial

KW - type 2 diabetes

U2 - 10.1111/dom.14633

DO - 10.1111/dom.14633

M3 - Journal article

C2 - 34984805

AN - SCOPUS:85123508602

SN - 1462-8902

VL - 24

SP - 693

EP - 703

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 4

ER -

Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial

Abstract

Bibliografisk note

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A Low-Carbohydrate Diet in Type 2 Diabetes: Effects over six months on glycemic control, cardiovascular risk factors, vascular endothelial function and pro-inflammatory markers

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