PROTOCOL 
        TITLE PAGE 
        Effects of Low Carbohydrate Diet (LCBD) on Weight 
        and Renal Outcome in Patients with Diabetic Kidney 
        Disease (DKD)- A pilot study 
        Primary Investigator: 
        Associate Professor Dr Rohana Abdul Ghani 
         
        Co-investigators: 
        Prof Dr Nafeeza bt Hj Mohd Ismail 
        Dr Aisyah bt Zainordin  
        Dr Ahmad Azhar bin Abdul Rahim  
        Cik Fatin Aqilah 
         
        Date of document preparation: 8th Oct 2018  
        Amended date: 10th Jun 2021 
                Effects of Low Carbohydrate Diet (LCBD) on Weight and Renal Outcome in 
                Patients with Diabetic Kidney Disease (DKD)- A pilot study 
                Investigator-initiated, single center, randomized, controlled, clinical trial in Type 2 
                diabetes mellitus patients.  
                INTRODUCTION 
                The current population of type 2 diabetes mellitus worldwide is over 200 million and 
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                Malaysia  contributes  to  1.2%  of  that  number .  Type  2  diabetes  mellitus  is  a 
                progressive disease associated with debilitating microvascular and macrovascular 
                complications. The prevalence of T2DM in Malaysia has approximately tripled over 
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                the last three decades from 6.3% in 1986 to 17.5% of the adult population in 2015 . 
                The prevalence of chronic kidney disease (CKD) in Peninsular Malaysia was high at 
                9.1% of the adult population in 2011. Among these, 4.2% patients were in CKD stage 
                1, 2.0% in CKD stage 2, 2.3% in CKD stage 3, 0.2% in CKD stage 4, and 0.4% 
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                in CKD  stage  5 .  Diabetes  is  the  leading  cause  of  renal  failure  for  patients 
                commencing dialysis, increasing from 53% of new dialysis patients in 2004 to 61% 
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                in 2013 . Therefore, diabetic kidney disease (DKD) is a debilitating complication 
                which not only imposes significant health problems but also confers financial burden 
                on affected patients. There has been increasing amount of understanding in the 
                complexity of the relationship between T2DM and obesity. As the prevalence of both 
                conditions continue to demonstrate a parallel rise, the influence of obesity on T2DM 
                is  further marked. Thus, this has led to greater emphasis on weight loss in the 
                management of T2DM. More recent anti-diabetic medications including SGLT-2 
                inhibitors and GLP1 agonists demonstrated greater efficacy in improving glycaemic 
                control and their ability to produce weight reduction. In addition, there has been more 
                interest in the effects of these drugs on retardation of renal disease progression. The 
                mechanism is unclear, either attributed by direct drug effects on renal glomerular-
                tubular structures, through the Renin-Angiotensin-Aldosterone-System (RAAS), or 
                other pathways. Another plausible explanation is the significant weight loss, which 
                has been shown to have a significant effect of attenuation of renal disease.  
                Weight reduction programs have long been a complex and tedious treatment plan 
                which has inconsistent, non-duplicable and unpredictable outcomes. Most programs 
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         emphasized on medical nutrition therapy and lifestyle changes. There have been 
         many different dietary plans which share a common goal ie to reduce calorie intake 
         whilst increasing energy expenditure. Few have been successfully reproducible, 
         limited by either patient adherence or modest outcome.  
         Low carbohydrate diet is a diet plan which stresses on reducing carbohydrate intake 
         to less than 20g daily. Numerous studies have shown that weight loss could be 
         obtained by reduction of calorie intake in either the form of carbohydrate or fat. CKD 
         patients are recommended to consume low protein diet of less than 0.6-0.7g/kg/day 
         with little emphasis on calorie or carbohydrate intake. 
         This study, thus, aims to evaluate the effects of low carbohydrate and moderate fat 
         (LCBD) in addition to low protein diet on renal disease in patients with DKD. 
         Objectives 
          1.  To evaluate the effects of LCBD in comparison to low protein diet (LPD) alone 
            on renal outcome in patients with DKD 
          2.  To evaluate the effects of LCBD in comparison to low protein diet (LPD) alone 
            on anthropometric and other metabolic parameters in patients with DKD  
          3.  To  determine  the  associations  between  renal  outcome  and  metabolic 
            parameters in patients with DKD who received LCBD and standard therapy. 
             
          
         OUTCOME MEASURES 
         Primary Outcome 
          1.  Proteinuria as assessed by UACR 
          2.  Rise in serum creatinine, reduction in eGFR  
         Secondary Outcomes 
         1. Weight loss, blood pressure 
         2.  Metabolic  parameters-  lipid  profile  and  inflammatory  markers  including 
         hsCRP, IL-6 
          
         HYPOTHESES 
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         LCBD  reduces  proteinuria  and  improves  renal  function  compared  to  standard 
         treatment in patients with DKD. 
         LCBD  causes  significant  weight  loss  and  improvement  in  other  metabolic 
         parameters compared to standard treatment in patients with DKD. 
          
                       
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