Low Carbohydrate Diet in Diabetic Kidney Disease

NCT04931030 | Completed DMC

• 1 other identifier: 600-IRMI (5/1/6)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Kidney Disease; Obesity

Keywords

low carbohydrate diet; chronic kidney disease; diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Change from baseline serum Creatinine at 12 weeks

  Creatinine in micromol/L

  Study end at 12 weeks

• Change from baseline urine microalbuminuria at 12 weeks

  Urine microalbuminuria in mmol/L

  Study end at 12 weeks

Secondary Outcomes (10)

• Change from baseline HbA1c at 12 weeks

  Study end at 12 weeks

• Change from baseline fasting plasma glucose at 12 weeks

  Study end at 12 weeks

• Change from baseline lipid levels at 12 weeks

  Study end at 12 weeks

• Change from baseline weight at 12 weeks

  Study end at 12 weeks

• Change from baseline hip circumference (HC) at 12 weeks

  Study end at 12 weeks

Study Arms (2)

Low carbohydrate diet (LCBD)

EXPERIMENTAL

Subjects are given a dietary prescription of 20g of carbohydrate daily in addition to standard low protein diet of 0.6-0.7g/kg/day and low salt diet.

Other: Dietary advice

Low protein diet only (LPD)

NO INTERVENTION

Subjects are given the standard dietary advice of chronic kidney disease of low protein diet of 0.6-0.7g/kg/day and low salt diet.

Interventions

Dietary advice OTHER

Subjects are provided dietary advice by the dietitians as part of the research team/ investigators

Low carbohydrate diet (LCBD)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Type 2 DM of more than 5 years
• Diagnosis of stable CKD of more than 6 months
• CKD stage 2 and 3
• HbA1c of 7% - 10.5%
• Patient age between 40-75 years old
• Able to sign informed consent

You may not qualify if:

• Type 1 DM
• Frequent hypoglycaemia
• Persistent elevations of serum transminase
• 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 for acute within the past 3 months
• Pregnant women, breastfeeding or planning to conceive within the next year

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• IMU University, Malaysia: collaborator

Study Sites (1)

Universiti Teknologi MARA

Petaling Jaya, Selangor, 47000, Malaysia

Location

Related Publications (4)

• Feisul MI, Azmi S. (Eds). National Diabetes Registry Report, Volume 1, 2009-2012. Kuala Lumpur; Ministry of Health Malaysia; 2013 Jul.

  BACKGROUND

• National Health and Morbidity Survey 2015 (NHMS 2015). Ministry of Health, Kuala Lumpur, Malaysia

  BACKGROUND

• Hooi LS, Ong LM, Ahmad G, Bavanandan S, Ahmad NA, Naidu BM, Mohamud WN, Yusoff MF. A population-based study measuring the prevalence of chronic kidney disease among adults in West Malaysia. Kidney Int. 2013 Nov;84(5):1034-40. doi: 10.1038/ki.2013.220. Epub 2013 Jun 12.

  PMID: 23760287 BACKGROUND

• B. Goh, L. Ong, Y. Lim. Twenty First Report of the Malaysian Dialysis and Transplant 2013. Malaysian Society of Nephrology, Kuala Lumpur, Malaysia (2014)

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Obesity; Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Dean Postgraduate Studies and Professional Training, Principal Investigator, Clinical Professor in Medicine

Model Details: Randomized, controlled, unblinded, dietary intervention

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 18, 2021
• Study Start: March 15, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

MY (1)