Improving insulin sensitivity, liver steatosis and fibrosis in type 2 diabetes by a food-based digital education-assisted lifestyle intervention program: a feasibility study

Oana P Zaharia, Yuliya Kupriyanova, Yanislava Karusheva, Daniel F Markgraf, Konstantinos Kantartzis, Andreas L Birkenfeld, Michael Trenell, Aarti Sahasranaman, Chris Cheyette, Theresa Kössler, Kálmán Bódis, Volker Burkart, Jong-Hee Hwang, Michael Roden, Julia Szendroedi, Dominik H Pesta, Oana P Zaharia, Yuliya Kupriyanova, Yanislava Karusheva, Daniel F Markgraf, Konstantinos Kantartzis, Andreas L Birkenfeld, Michael Trenell, Aarti Sahasranaman, Chris Cheyette, Theresa Kössler, Kálmán Bódis, Volker Burkart, Jong-Hee Hwang, Michael Roden, Julia Szendroedi, Dominik H Pesta

Abstract

Purpose: Recent trials demonstrated remission of type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) following formula diet-induced weight loss. To improve the outreach for populations in need, many mobile health apps targeting weight loss have been developed with limited scientific evaluation of these apps. The present feasibility study investigated the effects of a novel approach incorporating a regular 'whole food-based' low-calorie diet combined with app-based digital education and behavioral change program on glucose metabolism and disease management.

Methods: Twenty-four individuals with type 2 diabetes followed this approach supported by weekly coaching calls for 12 weeks. Phenotyping included bioimpedance analysis, mixed-meal tolerance test, magnetic resonance spectroscopy and transient elastography for assessing liver fat content and liver stiffness.

Results: Over 12 weeks, participants reduced their body weight by 9% (97 ± 13 to 88 ± 12 kg), body mass index (BMI; 33 ± 5 to 29 ± 4 kg/m2), total fat mass (31 ± 10 to 27 ± 10%) (all p < 0.01) and liver fat by 50% alongside with decreased liver stiffness. Target HbA1c (< 6.5%) was achieved by 38% and resolution of NAFLD (liver fat content < 5.6%) was observed in 30% of the participants.

Conclusion: This novel approach combining digital education with a low-calorie diet results in effective improvements of body weight, glycemic control and NAFLD and could complement existing care for patients with type 2 diabetes.

Trial registration: NCT04509245.

Keywords: Diabetes management; Digital education; Insulin sensitivity; Non-alcoholic fatty liver disease; Type 2 diabetes.

Conflict of interest statement

Michael Roden serves as investigator of studies supported by Boehringer-Ingelheim Pharma, Nutriticia / Danone and Sanofi and has served as advisor/consultant for Bristol-Myers Squibb, Eli Lilly, Gilead, Intercept Pharma, Novo Nordisk, Novartis, Poxel, Prosciento, Sanofi, Servier and TARGET NASH. Michael Trenell is co-founder of Changing Health Ltd, a spin-out company from Newcastle University and Newcastle upon Tyne NHS Hospitals Trust. Chris Cheyette authored the recipe book ‘Carbs & Cals’ and is managing director at Chello Publishing Limited.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Recruitment flow diagram
Fig. 2
Fig. 2
Metabolic parameters before and after the intervention. Glycemic control (a, b) and insulin sensitivity (c), cardiovascular parameters: blood pressure (d, e) and resting heart rate (f) and liver parameters: HCL (g), ALT (h) and stiffness (i). Black bars represent baseline data while post-intervention data are shown as grey bars. *p < 0.05; **p < 0.01. Significant differences as determined by paired samples t-test for pre-post comparison. ALT alanine aminotransferase, BP blood pressure, HbA1c glycated hemoglobin, OGIS oral glucose insulin sensitivity index
Fig. 3
Fig. 3
Metabolic response to mixed-meal tolerance test before and after intervention. Metabolic parameters during the mixed-meal test before and after the intervention: glycemia (a), insulin secretion (b), free fatty acids (c) and triglycerides (d). Black dots and respective error bars represent baseline data while post-intervention data are shown as white dots and respective error bars. *p < 0.05. Significant differences as determined by paired samples t-test for pre-post comparison

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