Efficacy and Safety of Phase 1 of Very Low Energy Ketogenic Therapy (VLEKT) in Subjects with Obesity and Mild Renal Impairment

<b>Background:</b> Obesity impairs renal function through direct mechanisms, such as proinflammatory adipocytokine production, and indirect mechanisms, including obesity-related comorbidities. Despite the increasing prevalence of obesity and chronic kidney disease (CKD), clinical guidelines for their combined management remain lacking. Very Low Energy Ketogenic Therapy (VLEKT) has demonstrated efficacy in weight loss, but evidence on its safety and efficacy in individuals with obesity and mild renal impairment is limited. This study aimed to assess the efficacy and safety of Phase 1 of VLEKT in individuals with obesity and mild renal impairment. <b>Methods:</b> This cross-sectional study included 73 individuals with overweight or obesity (mean age 53.7 ± 8.8 years; BMI 35.3 ± 4.2 kg/m<sup>2</sup>) and an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m<sup>2</sup> (evaluated using the CKD-EPI equation). Anthropometric (weight, BMI, and waist circumference) and biochemical parameters (fasting plasma glucose, insulin, cholesterol profile, triglycerides, AST, ALT, and urea) were collected at baseline and after 45 (±2) days of Phase 1 of VLEKT. <b>Results:</b> At baseline, 54.8% of participants had an eGFR <90 mL/min/1.73 m<sup>2</sup>, while 45.2% had an eGFR ≥ 90 mL/min/1.73 m<sup>2</sup>, with no significant differences in sex distribution. After 45 (±2) days of Phase 1 of VLEKT, both groups showed significant reductions in BMI (<i>p</i> < 0.001), waist circumference (<i>p</i> < 0.001), fasting plasma glucose (<i>p</i> ≤ 0.004), insulin (<i>p</i> < 0.001), HOMA-IR (<i>p</i> < 0.001), total cholesterol (<i>p</i> < 0.001), LDL cholesterol (<i>p</i> < 0.001), LDL/HDL ratio (<i>p</i> ≤ 0.002), triglycerides (<i>p</i> ≤ 0.009), AST (<i>p</i> ≤ 0.034), and ALT (<i>p</i> ≤ 0.009). Notably, the eGFR significantly increased in participants with an eGFR < 90 mL/min/1.73 m<sup>2</sup> (<i>p</i> < 0.001), while no changes were observed in those with an eGFR ≥ 90 mL/min/1.73 m<sup>2</sup>. <b>Conclusions:</b> Phase 1 of VLEKT could effectively promote weight loss and metabolic improvements without compromising renal function, even in individuals with obesity and mild renal impairment. Further research is warranted to confirm the efficacy and safety of VLEKT and to assess outcomes across all protocol phases.

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Journal
Nutrients
Published
2025-02-18
DOI
https://doi.org/10.3390/nu17040721
Citations
2
Primary Topic
Diet and metabolism studies
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article
Field-Weighted Citation Impact
2.33
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article

Efficacy and Safety of Phase 1 of Very Low Energy Ketogenic Therapy (VLEKT) in Subjects with Obesity and Mild Renal Impairment

Stefania De Luca, Annamaria Colao, Marilisa Galasso, Ludovica Verde et al.
2 citations
Nutrients
Diet and metabolism studies
2.33
article

Efficacy and Safety of Phase 1 of Very Low Energy Ketogenic Therapy (VLEKT) in Subjects with Obesity and Mild Renal Impairment

Stefania De Luca, Annamaria Colao, Marilisa Galasso, Ludovica Verde, Massimiliano Caprio, Giovanna Muscogiuri, Antonio Pisani, Luigi Barrea, Elisabetta Camajani
article en
2 citations

Abstract

<b>Background:</b> Obesity impairs renal function through direct mechanisms, such as proinflammatory adipocytokine production, and indirect mechanisms, including obesity-related comorbidities. Despite the increasing prevalence of obesity and chronic kidney disease (CKD), clinical guidelines for their combined management remain lacking. Very Low Energy Ketogenic Therapy (VLEKT) has demonstrated efficacy in weight loss, but evidence on its safety and efficacy in individuals with obesity and mild renal impairment is limited. This study aimed to assess the efficacy and safety of Phase 1 of VLEKT in individuals with obesity and mild renal impairment. <b>Methods:</b> This cross-sectional study included 73 individuals with overweight or obesity (mean age 53.7 ± 8.8 years; BMI 35.3 ± 4.2 kg/m<sup>2</sup>) and an estimated glomerular filtration rate (eGFR) of at least 60 mL/min/1.73 m<sup>2</sup> (evaluated using the CKD-EPI equation). Anthropometric (weight, BMI, and waist circumference) and biochemical parameters (fasting plasma glucose, insulin, cholesterol profile, triglycerides, AST, ALT, and urea) were collected at baseline and after 45 (±2) days of Phase 1 of VLEKT. <b>Results:</b> At baseline, 54.8% of participants had an eGFR <90 mL/min/1.73 m<sup>2</sup>, while 45.2% had an eGFR ≥ 90 mL/min/1.73 m<sup>2</sup>, with no significant differences in sex distribution. After 45 (±2) days of Phase 1 of VLEKT, both groups showed significant reductions in BMI (<i>p</i> < 0.001), waist circumference (<i>p</i> < 0.001), fasting plasma glucose (<i>p</i> ≤ 0.004), insulin (<i>p</i> < 0.001), HOMA-IR (<i>p</i> < 0.001), total cholesterol (<i>p</i> < 0.001), LDL cholesterol (<i>p</i> < 0.001), LDL/HDL ratio (<i>p</i> ≤ 0.002), triglycerides (<i>p</i> ≤ 0.009), AST (<i>p</i> ≤ 0.034), and ALT (<i>p</i> ≤ 0.009). Notably, the eGFR significantly increased in participants with an eGFR < 90 mL/min/1.73 m<sup>2</sup> (<i>p</i> < 0.001), while no changes were observed in those with an eGFR ≥ 90 mL/min/1.73 m<sup>2</sup>. <b>Conclusions:</b> Phase 1 of VLEKT could effectively promote weight loss and metabolic improvements without compromising renal function, even in individuals with obesity and mild renal impairment. Further research is warranted to confirm the efficacy and safety of VLEKT and to assess outcomes across all protocol phases.

NutrientsVol. 17(4)
University of Salerno (IT), University of Arizona (US), San Raffaele University of Rome (IT), Federico II University Hospital (IT), Pegaso University (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), University of Naples Federico II (IT)
Openalex Percentile: Top 14%
Diet and metabolism studies
2.33
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