Renal structure and function in type 2 diabetes

ISRCTN	ISRCTN77299467
DOI	https://doi.org/10.1186/ISRCTN77299467
Secondary identifying numbers	N/A

Submission date: 08/02/2011
Registration date: 17/02/2011
Last edited: 17/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tatsumi Moriya
Scientific

Endocrinology, Diabetes and Metabolism
1-15-1 Kitasato, Minami-ku
Sagamihara
252-0374
Japan

Study information

Study design	Observational longitudinal case-control single-centre study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Renal structure and function in type 2 diabetes: an observational, longitudinal case-control and single-centred study
Study objectives	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(s)	Research Ethics Committee of Kitasato University School of Medicine approved on the 22nd April 2004 (ref: B04-02)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/1998
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key 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
Key exclusion criteria	1. Receiving antihypertensive drugs 2. With a past history of any malignant, cerebrovascular or cardiovascular disease 3. With recurrent infection
Date of first enrolment	01/04/1998
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

Japan

Study participating centre

Endocrinology, Diabetes and Metabolism

Sagamihara
252-0374
Japan

Sponsor information

Kitasato University School of Medicine (Japan)
University/education

c/o Dr Tatsumi Moriya
Endocrinology, Diabetes and Metabolism
1-15-1 Kitasato, Minami-ku
Sagamihara
252-0374
Japan

Website	http://www.kitasato-u.ac.jp/
"ROR"	https://ror.org/00f2txz25

Funders

Funder type

Research organisation

Kitasato University Alumni Association (Japan) - pays incidental costs

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan