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Low Carbohydrate Diet in Diabetic Kidney Disease

10 giugno 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Contatti e Sedi

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Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Subjects are provided dietary advice by the dietitians as part of the research team/ investigators
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline serum Creatinine at 12 weeks
Lasso di tempo: Study end at 12 weeks
Creatinine in micromol/L
Study end at 12 weeks
Change from baseline urine microalbuminuria at 12 weeks
Lasso di tempo: Study end at 12 weeks
Urine microalbuminuria in mmol/L
Study end at 12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline HbA1c at 12 weeks
Lasso di tempo: Study end at 12 weeks
HbA1c in %
Study end at 12 weeks
Change from baseline fasting plasma glucose at 12 weeks
Lasso di tempo: Study end at 12 weeks
FPG in mmol/L
Study end at 12 weeks
Change from baseline lipid levels at 12 weeks
Lasso di tempo: Study end at 12 weeks
Cholesterol in mmol/L
Study end at 12 weeks
Change from baseline weight at 12 weeks
Lasso di tempo: Study end at 12 weeks
Weight in kg
Study end at 12 weeks
Change from baseline hip circumference (HC) at 12 weeks
Lasso di tempo: Study end at 12 weeks
HC in cm
Study end at 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
Lasso di tempo: 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
Lasso di tempo: Study end at 12 weeks
Est VAT in %
Study end at 12 weeks
Change from baseline blood pressure at 12 weeks
Lasso di tempo: 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
Lasso di tempo: Study end at 12 weeks
hsCRP in nmol/L
Study end at 12 weeks
Change from baseline Interleukin-6 (IL-6) at 12 weeks
Lasso di tempo: Study end at 12 weeks
IL-6 in pg/mL
Study end at 12 weeks

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 marzo 2019

Completamento primario (Effettivo)

5 marzo 2021

Completamento dello studio (Effettivo)

5 marzo 2021

Date di iscrizione allo studio

Primo inviato

1 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2021

Primo Inserito (Effettivo)

18 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2021

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

Unidentified subjects' raw data is required for some journal submissions

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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