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Effects of nutritional intervention on the clinical parameters associated with diabetic nephropathy in patients with type 2 diabetes mellitus: a randomized, controlled trial

Effects of nutritional intervention on the clinical, physical and nutritional parameters associated with the development and progression of type 2 diabetic nephropathy: a randomized, controlled trial - Succeed trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043955
Enrollment
200
Registered
2021-04-17
Start date
2013-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

An intensive intervention group that received nutritional education at every outpatient visit An usual intervention group that received nutritional education only once a year

Sponsors

Jichi Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus and DKD caused by type 2 diabetes (CKD stage G1-3) aged 20 years or older who attended the Division of Endocrinology and Metabolism and the Division of Nephrology at Jichi Medical University Hospital between May 2013 and October 2016 and had not received nutritional education in the past 5 years were included in the study.

Exclusion criteria

Exclusion criteria: Patients who have received individual nutritional guidance by a registered dietitian at our hospital in the past. Minors and those who have difficulty in obtaining informed consent from the patient Patients with stage G4 or G5 chronic kidney disease Patients with extremely poor blood glucose control with HbA1c of 10% or higher Patients with nephrotic syndrome Patients with type 1 diabetes mellitus Patients with hereditary and secondary diabetes mellitus Patients with primary and secondary glomerular diseases other than diabetes mellitus Patients with secondary hypertension Patients with unstable angina pectoris, myocardial infarction or stroke within 6 months prior to the start of the study Patients with malignancy or life-threatening diseases that may cause death within 2 years Patients with hepatic dysfunction (AST or ALT of 100 mU/ml or higher, or obvious liver cirrhosis) Patients who are pregnant or intend to become pregnant during the study period. Other patients who are judged by the attending physician to be inappropriate for the study

Design outcomes

Primary

MeasureTime frame
Differences in clinical, physical and nutritional factors over time between the intensive intervention and control groups during the first two years of the study, and association of improved or worsening nutritional and clinical factors.

Secondary

MeasureTime frame
Achievement of treatment goals for levels of control of weight, blood pressure, blood glucose, and serum lipids

Countries

Japan

Contacts

Public ContactNao Kawabata

Jichi Medical University Hospital Department of Clinical Nutrition

nkawabata@jichi.ac.jp+81285587574

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026