Low Protein Diet Supplemented With Ketoanalogs on Reducing Proteinuria and Maintaining Nutritional Status in Type 2 Diabetic Nephropathy

NCT01300273 | Unknown Phase 4

• 1 other identifier: KETO-011-IP4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that, LPD supplemented with ketoanalogs will reduce urine podocyte loss and lower the angiotensinogen level in the urine.

Conditions

Type 2 Diabetic Nephropathy

Keywords

Diabetic nephropathy; Podocyte; Low Protein Diet; Ketoanalogs

Outcome Measures

Primary Outcomes (1)

• monitor podocyte loss by detecting nephrin, podocin, and synaptopodin mRNA in urine particulates with quantitative reverse transcriptase-PCR.

  At baseline and every 3 months, a whole-stream early morning urine specimen will be collected for gene expression study.

  At baseline and every 3 months

Study Arms (1)

Ketosteril

EXPERIMENTAL

Dietary Supplement: Compound α-Ketoacid Tablet

Interventions

Compound α-Ketoacid Tablet DIETARY_SUPPLEMENT

30 patients will be treated with a LPD containing 0.6g protein/kg BW per day and 120-125 kJ/kg BW per day and supplemented with keto-amino acids (Ketosteril®, Fresenius Kabi) at a dosage of 100 mg/kg BW per day.

Also known as: Ketosteril, Ketoanalogs

Ketosteril

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with type 2 diabetes
• age range is 18 - 80 years old
• no gender restrictions
• use oral hypoglycemic agents (limited to repaglinide, α-glucosidase inhibitor and chloroquine ketone) and/or insulin to control blood sugar
• fasting blood sugar is not higher than 10mmol/l, glycated hemoglobin is not higher than 8.5%
• using RAS system blockers (ACEI or ARB) for at least 4 weeks and blood pressure is no higher than 160/90mmHg. Once enrolled in the group, the dose should not be changed, unless there is contraindication
• has not yet started dialysis, GFR based on simplified MDRD formula is between (15-60) ml/min/1.73m2
• serum albumin is not less than 25g/l and appearing dominant proteinuria (urinary albumin excretion rate \> 300mg/24h)
• understanding and willing to participate in the trial and signed informed consent

You may not qualify if:

• compliance is poor
• GFR \< 15ml/min/1.73m2
• repeated hypercalcemia, hyperkalemia
• ketoacidosis occurred in recent 6 months
• chronic heart failure, above NYHA 3 grade
• combined with other serious diseases in 3 months
• obvious symptoms and signs of liver disease. Alanine or aspartate aminotransferase 2 times higher than normal
• severe edema, or up to the level of nephrotic syndrome or that there is serous cavity effusion
• urinary tract infections or other urinary tract diseases
• drug abusers
• diagnosed of malignancy
• receiving long-term systemic steroid therapy
• women pregnancy or Intended pregnancy and breastfeeding
• took part in other clinical drug studies 30 days before the trial

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Huashan Hospital: collaborator
• Shanghai East Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator

Study Sites (1)

Department of Nephrology,Shanghai Jiaotong University Affiliated First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (8)

• Kasiske BL, Lakatua JD, Ma JZ, Louis TA. A meta-analysis of the effects of dietary protein restriction on the rate of decline in renal function. Am J Kidney Dis. 1998 Jun;31(6):954-61. doi: 10.1053/ajkd.1998.v31.pm9631839.

  PMID: 9631839 BACKGROUND

• Mahmood J, Khan F, Okada S, Kumagai N, Morioka T, Oite T. Local delivery of angiotensin receptor blocker into the kidney ameliorates progression of experimental glomerulonephritis. Kidney Int. 2006 Nov;70(9):1591-8. doi: 10.1038/sj.ki.5001872. Epub 2006 Sep 20.

  PMID: 16985512 BACKGROUND

• Wang G, Lai FM, Lai KB, Chow KM, Li KT, Szeto CC. Messenger RNA expression of podocyte-associated molecules in the urinary sediment of patients with diabetic nephropathy. Nephron Clin Pract. 2007;106(4):c169-79. doi: 10.1159/000104428. Epub 2007 Jun 26.

  PMID: 17596726 BACKGROUND

• Wang G, Lai FM, Lai KB, Chow KM, Kwan BC, Li PK, Szeto CC. Urinary messenger RNA expression of podocyte-associated molecules in patients with diabetic nephropathy treated by angiotensin-converting enzyme inhibitor and angiotensin receptor blocker. Eur J Endocrinol. 2008 Mar;158(3):317-22. doi: 10.1530/EJE-07-0708.

  PMID: 18299464 BACKGROUND

• Yamamoto T, Nakagawa T, Suzuki H, Ohashi N, Fukasawa H, Fujigaki Y, Kato A, Nakamura Y, Suzuki F, Hishida A. Urinary angiotensinogen as a marker of intrarenal angiotensin II activity associated with deterioration of renal function in patients with chronic kidney disease. J Am Soc Nephrol. 2007 May;18(5):1558-65. doi: 10.1681/ASN.2006060554. Epub 2007 Apr 4.

  PMID: 17409316 BACKGROUND

• Adey D, Kumar R, McCarthy JT, Nair KS. Reduced synthesis of muscle proteins in chronic renal failure. Am J Physiol Endocrinol Metab. 2000 Feb;278(2):E219-25. doi: 10.1152/ajpendo.2000.278.2.E219.

  PMID: 10662705 BACKGROUND

• Sato N, Komatsu K, Kurumatani H. Late onset of diabetic nephropathy in spontaneously diabetic GK rats. Am J Nephrol. 2003 Sep-Oct;23(5):334-42. doi: 10.1159/000072915. Epub 2003 Aug 13.

  PMID: 12920324 BACKGROUND

• Verity MA. Infantile Pompe's disease, lipid storage, and partial carnitine deficiency. Muscle Nerve. 1991 May;14(5):435-40. doi: 10.1002/mus.880140509.

  PMID: 1870635 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

ketosteril

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Weijie Yuan, Professor

  Department of Nephrology, First People's Hospital, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Director of Department of Nephrology

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

CN (1)