Safety and efficacy of very low carbohydrate diet in patients with diabetic kidney disease-A randomized controlled trial.
Study Goal
The researchers aimed to determine the safety and effects of a very low carbohydrate diet (VLCBD) combined with a low protein diet (LPD) on renal outcomes, metabolic parameters, and inflammatory markers in patients with type 2 diabetes and mild to moderate kidney disease.
Results Summary
The VLCBD group showed significant improvements in glycemic control, weight reduction, body fat percentages, and IL-6 levels, with no worsening of renal function. Both dietary interventions were well-tolerated with no reported adverse events.
Population
Patients with type 2 diabetes and mild to moderate diabetic kidney disease (n = 30, median age 57, BMI 30.68 kg/m²).
Effective Dosage
<20g carbohydrates daily (VLCBD) vs. 0.8g/kg/day protein (control).
Duration
12 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
very low carbohydrate diet (VLCBD) in addition to low protein diet (LPD) | neutral | renal outcomes, anthropometric, metabolic and inflammatory parameters | patients with T2DM and underlying mild to moderate kidney disease (DKD) | - | determined the safety and effects | #1 |
low carbohydrate diet (<20g daily intake) | decrease | daily carbohydrate intake | patients with T2DM and DKD | 27 (IQR25) g vs 89.33 (IQR77.4) g, p<0.001 | showed significantly lower daily carbohydrate intake | #2 |
low carbohydrate diet (<20g daily intake) | increase | protein intake per day | patients with T2DM and DKD | 44.08 (IQR21.98) g vs 29.63 (IQR16.35) g, p<0.05 | significantly higher protein intake per day | #3 |
low carbohydrate diet (<20g daily intake) | no change | daily fat intake | patients with T2DM and DKD | - | no difference in daily fat intake | #4 |
low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet | no change | serum creatinine | patients with T2DM and DKD | - | showed no worsening of serum creatinine | #5 |
low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet | decrease | HbA1c | patients with T2DM and DKD | 1.3(1.1) vs 0.7(1.25) % | consistent declines in HbA1c | #6 |
low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet | decrease | fasting blood glucose | patients with T2DM and DKD | 1.5(3.37) vs 1.3(5.7) mmol/L | consistent declines in fasting blood glucose | #7 |
low carbohydrate diet (<20g daily intake) | decrease | total daily insulin dose | patients with T2DM and DKD | 39(22) vs 0 IU, p<0.001 | significant reductions in total daily insulin dose | #8 |
low carbohydrate diet (<20g daily intake) | increase | LDL-C | patients with T2DM and DKD | - | increased LDL-C | #9 |
low carbohydrate diet (<20g daily intake) | increase | HDL-C | patients with T2DM and DKD | - | increased HDL-C | #10 |
low carbohydrate diet (<20g daily intake) | decrease | IL-6 levels | patients with T2DM and DKD | - | decline in IL-6 levels | #11 |
low carbohydrate diet (<20g daily intake) | decrease | weight | patients with T2DM and DKD | -4.0(3.9) vs 0.2(4.2) kg, p = <0.001 | significant weight reduction | #12 |
low carbohydrate diet (<20g daily intake) | decrease | body fat percentages | patients with T2DM and DKD | - | improvements in body fat percentages | #13 |
low carbohydrate diet (<20g daily intake) | decrease | WC | patients with T2DM and DKD | - | WC was significantly reduced | #14 |
very low carbohydrate diet | decrease | glycemic control, anthropometric measurements including weight, abdominal adiposity and IL-6 | patients with underlying diabetic kidney disease | - | was safe and associated with significant improvements in glycemic control, anthropometric measurements including weight, abdominal adiposity and IL-6 | #15 |
very low carbohydrate diet | no change | Renal outcomes | patients with underlying diabetic kidney disease | - | Renal outcomes remained unchanged | #16 |
INTRODUCTION: There is limited data on the effects of low carbohydrate diets on renal outcomes particularly in patients with underlying diabetic kidney disease. Therefore, this study determined the safety and effects of very low carbohydrate (VLCBD) in addition to low protein diet (LPD) on renal outcomes, anthropometric, metabolic and inflammatory parameters in patients with T2DM and underlying mild to moderate kidney disease (DKD). MATERIALS AND METHODS: This was an investigator-initiated, single-center, randomized, controlled, clinical trial in patients with T2DM and DKD, comparing 12-weeks of low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet. Patients in the VLCBD group underwent 2-weekly monitoring including their 3-day food diaries. In addition, Dual-energy x-ray absorptiometry (DEXA) was performed to estimate body fat percentages. RESULTS: The study population (n = 30) had a median age of 57 years old and a BMI of 30.68kg/m2. Both groups showed similar total calorie intake, i.e. 739.33 (IQR288.48) vs 789.92 (IQR522.4) kcal, by the end of the study. The VLCBD group showed significantly lower daily carbohydrate intake 27 (IQR25) g vs 89.33 (IQR77.4) g, p<0.001, significantly higher protein intake per day 44.08 (IQR21.98) g vs 29.63 (IQR16.35) g, p<0.05 and no difference in in daily fat intake. Both groups showed no worsening of serum creatinine at study end, with consistent declines in HbA1c (1.3(1.1) vs 0.7(1.25) %) and fasting blood glucose (1.5(3.37) vs 1.3(5.7) mmol/L). The VLCBD group showed significant reductions in total daily insulin dose (39(22) vs 0 IU, p<0.001), increased LDL-C and HDL-C, decline in IL-6 levels; with contrasting results in the control group. This was associated with significant weight reduction (-4.0(3.9) vs 0.2(4.2) kg, p = <0.001) and improvements in body fat percentages. WC was significantly reduced in the VLCBD group, even after adjustments to age, HbA1c, weight and creatinine changes. Both dietary interventions were well received with no reported adverse events. CONCLUSION: This study demonstrated that dietary intervention of very low carbohydrate diet in patients with underlying diabetic kidney disease was safe and associated with significant improvements in glycemic control, anthropometric measurements including weight, abdominal adiposity and IL-6. Renal outcomes remained unchanged. These findings would strengthen the importance of this dietary intervention as part of the management of patients with diabetic kidney disease.