Low Carbohydrate Diet in Diabetic Kidney Disease
Condition: Type 2 Diabetes Mellitus; Diabetic Kidney Disease; Obesity
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The current population of type 2 diabetes mellitus (T2DM) worldwide is over 200 million and
      Malaysia contributes to 1.2% of that number. The prevalence of T2DM in Malaysia has
      approximately tripled over the last three decades from 6.3% in 1986 to 17.5% of the adult
      population in 2015.T2DM is a progressive disease associated with debilitating microvascular
      and macrovascular complications. The prevalence of chronic kidney disease (CKD) in Peninsular
      Malaysia was high at 9.1% of the adult population in 2011. T2DM is the leading cause of renal
      failure for patients commencing dialysis, increasing from 53% of new dialysis patients in
      2004 to 61% 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 pausible 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 emphasized on medical
      nutrition therapy and lifestyle changes. There has been many different dietary plans which
      share a common goal ie to reduce calori 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 calori 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 calori 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.
    

Detailed description: 
      This is an investigator-initiated, single center, randomized, controlled, clinical trial in
      Type 2 diabetes mellitus patients, comparing 16-weeks of LCBD compared to standard medical
      therapy in patients with DKD.

      Patients would be recruited from the Endocrinology and Nephrology clinics in UiTM Medical
      Specialist Center. Inclusion criteria would include patients aged between 40-75 years old,
      diagnosis with Type 2 DM of more than 5 years with stable CKD stage 2 and 3 of more than 6
      months, HbA1c of 7% - 10.5%.

      Exclusion Criteria include patients with Type 1 DM, experiencing frequent hypoglycaemia,
      abnormal liver function tests, heart failure (New York Heart Association functional class
      III-IV), active systemic inflammatory disease, chronic renal failure requiring hemodialysis,
      active hepatic disease and collagen disease, malignancy, recent hospital admission within the
      past 3 months, pregnant women, breastfeeding or planning to conceive within the next year.

      Following informed consent, patients would be randomised to either LCBD or low protein Diet
      (LPD) group.

      All recruited patients will be given the standard dietary and exercise advice which will
      include low protein of 0.6-0.7g/kg/day and low salt diet.

      In addition, patients within the LCBD will be given a prescription diet of 20g of
      carbohydrate daily. This will be supplemented by visual aids on carbohydrate counts of
      various local food. Patients would be given the option to choose their most appropriate food
      types which will amount to the carbohydrate count given. Patients on oral anti-diabetic
      treatment including insulin will advised on titrations of their medications to avoid
      hypoglycaemia.

      The control arm will not be given any additional advice. All patients will be required to
      fill in a 3-day food diary during their scheduled visits which will be at 8 weeks and 16
      weeks.

      Clinical assessments include blood sampling of approximately 8 ml which will be done at
      baseline and at study end.
    

Intervention name(s): Dietary advice
Intervention type(s): Other
Intervention description(s): Subjects are provided dietary advice by the dietitians as part of the research team/ investigators
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, unblinded, dietary intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low carbohydrate diet; chronic kidney disease; diabetes mellitus