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

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000043955
• Lead Sponsor: Jichi Medical University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-17
• Study Completion: 2021-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Achievement of treatment goals for levels of control of weight, blood pressure, blood glucose, and serum lipids