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Low Carbohydrate Diet in Diabetic Kidney Disease

2021年6月10日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Selangor
      • Petaling Jaya、Selangor、マレーシア、47000
        • Universiti Teknologi Mara

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline serum Creatinine at 12 weeks
時間枠:Study end at 12 weeks
Creatinine in micromol/L
Study end at 12 weeks
Change from baseline urine microalbuminuria at 12 weeks
時間枠:Study end at 12 weeks
Urine microalbuminuria in mmol/L
Study end at 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline HbA1c at 12 weeks
時間枠:Study end at 12 weeks
HbA1c in %
Study end at 12 weeks
Change from baseline fasting plasma glucose at 12 weeks
時間枠:Study end at 12 weeks
FPG in mmol/L
Study end at 12 weeks
Change from baseline lipid levels at 12 weeks
時間枠:Study end at 12 weeks
Cholesterol in mmol/L
Study end at 12 weeks
Change from baseline weight at 12 weeks
時間枠:Study end at 12 weeks
Weight in kg
Study end at 12 weeks
Change from baseline hip circumference (HC) at 12 weeks
時間枠:Study end at 12 weeks
HC in cm
Study end at 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
時間枠: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
時間枠:Study end at 12 weeks
Est VAT in %
Study end at 12 weeks
Change from baseline blood pressure at 12 weeks
時間枠: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
時間枠:Study end at 12 weeks
hsCRP in nmol/L
Study end at 12 weeks
Change from baseline Interleukin-6 (IL-6) at 12 weeks
時間枠:Study end at 12 weeks
IL-6 in pg/mL
Study end at 12 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年3月15日

一次修了 (実際)

2021年3月5日

研究の完了 (実際)

2021年3月5日

試験登録日

最初に提出

2021年6月1日

QC基準を満たした最初の提出物

2021年6月10日

最初の投稿 (実際)

2021年6月18日

学習記録の更新

投稿された最後の更新 (実際)

2021年6月18日

QC基準を満たした最後の更新が送信されました

2021年6月10日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Unidentified subjects' raw data is required for some journal submissions

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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