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Low Carbohydrate Diet in Diabetic Kidney Disease

10 juni 2021 bijgewerkt door: Rohana Abdul Ghani, Universiti Teknologi Mara

Effects of Low Carbohydrate Diet (LCBD) on Weight and Renal Outcome in Patients With Diabetic Kidney Disease (DKD)- A Pilot Study

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Maleisië
    • Selangor
      • Petaling Jaya, Selangor, Maleisië, 47000
        • Universiti Teknologi Mara

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria

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

Exclusion Criteria

  1. Type 1 DM
  2. Frequent hypoglycaemia
  3. Persistent elevations of serum transminase
  4. 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
  5. Malignancy
  6. Recent hospital admission for acute within the past 3 months
  7. Pregnant women, breastfeeding or planning to conceive within the next year

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Low carbohydrate diet (LCBD)
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.
Ander: Dietary advice
Subjects are provided dietary advice by the dietitians as part of the research team/ investigators
Geen tussenkomst: Low protein diet only (LPD)
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline serum Creatinine at 12 weeks
Tijdsspanne: Study end at 12 weeks
Creatinine in micromol/L
Study end at 12 weeks
Change from baseline urine microalbuminuria at 12 weeks
Tijdsspanne: Study end at 12 weeks
Urine microalbuminuria in mmol/L
Study end at 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline HbA1c at 12 weeks
Tijdsspanne: Study end at 12 weeks
HbA1c in %
Study end at 12 weeks
Change from baseline fasting plasma glucose at 12 weeks
Tijdsspanne: Study end at 12 weeks
FPG in mmol/L
Study end at 12 weeks
Change from baseline lipid levels at 12 weeks
Tijdsspanne: Study end at 12 weeks
Cholesterol in mmol/L
Study end at 12 weeks
Change from baseline weight at 12 weeks
Tijdsspanne: Study end at 12 weeks
Weight in kg
Study end at 12 weeks
Change from baseline hip circumference (HC) at 12 weeks
Tijdsspanne: Study end at 12 weeks
HC in cm
Study end at 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
Tijdsspanne: Study end at 12 weeks
WC in cm
Study end at 12 weeks
Change from baseline estimated visceral adispose tissue (Est VAT) at 12 weeks
Tijdsspanne: Study end at 12 weeks
Est VAT in %
Study end at 12 weeks
Change from baseline blood pressure at 12 weeks
Tijdsspanne: Study end at 12 weeks
Blood pressure in mmHg
Study end at 12 weeks
Change from baseline highly sensitivity C-reactive protein (hsCRP) at 12 weeks
Tijdsspanne: Study end at 12 weeks
hsCRP in nmol/L
Study end at 12 weeks
Change from baseline Interleukin-6 (IL-6) at 12 weeks
Tijdsspanne: Study end at 12 weeks
IL-6 in pg/mL
Study end at 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universiti Teknologi Mara

Medewerkers

International Medical University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 maart 2019

Primaire voltooiing (Werkelijk)

5 maart 2021

Studie voltooiing (Werkelijk)

5 maart 2021

Studieregistratiedata

Eerst ingediend

1 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2021

Eerst geplaatst (Werkelijk)

18 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2021

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 600-IRMI (5/1/6)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Unidentified subjects' raw data is required for some journal submissions

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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