Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Renal structure and function in type 2 diabetes: an observational, longitudinal case-control and single-centred study
Acronym
Study hypothesis
Little is known about the relationships between renal structural changes and the glomerular filtration rate (GFR). To elucidate renal structural-functional relationships in the early stage of diabetic nephropathy in type 2 diabetes, we performed a detailed analysis of renal morphology and its relationship with GFR. Finally, we studied whether glomerular hyperfiltration can predict further functional changes.
Ethics approval
Research Ethics Committee of Kitasato University School of Medicine approved on the 22nd April 2004 (ref: B04-02)
Study design
Observational longitudinal case-control single-centre study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diabetic nephropathy, renal structural changes
Intervention
Thirty type 2 diabetic patients showing either normoalbuminuria or microalbuminuria participated. Microscopic morphometric analyses provided quantitative glomerular structural changes. Patients were followed every 6 months for an average of 6.2 ± 3.5 years and glomerular filtration rate was determined.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The GFR measured by the plasma clearance of unlabeled iohexol. The plasma concentration of iohexol was measured by HPLC. Measured every 6 months after renal biopsy.
Secondary outcome measures
The urinary albumin measured by turbidimetric immunoassay. Measured every 6 months after renal biopsy.
Overall trial start date
01/04/1998
Overall trial end date
31/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Normotensive type 2 diabetic patients
2. Without overt proteinuria, haematuria or renal dysfunction
3. Without any evidence suggesting atherosclerotic diseases
4. Living kidney donors served as healthy controls
5. Aged 20 - 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Receiving antihypertensive drugs
2. With a past history of any malignant, cerebrovascular or cardiovascular disease
3. With recurrent infection
Recruitment start date
01/04/1998
Recruitment end date
31/03/2008
Locations
Countries of recruitment
Japan
Trial participating centre
Endocrinology, Diabetes and Metabolism
Sagamihara
252-0374
Japan
Sponsor information
Organisation
Kitasato University School of Medicine (Japan)
Sponsor details
c/o Dr Tatsumi Moriya
Endocrinology
Diabetes and Metabolism
1-15-1 Kitasato
Minami-ku
Sagamihara
252-0374
Japan
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Kitasato University Alumni Association (Japan) - pays incidental costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary