Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2011
Date assigned
17/02/2011
Last edited
17/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tatsumi Moriya

ORCID ID

Contact details

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

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

http://www.kitasato-u.ac.jp/

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

Publication citations

Additional files

Editorial Notes