Renal structure and function in type 2 diabetes
| ISRCTN | ISRCTN77299467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77299467 |
| Protocol serial number | N/A |
| Sponsor | Kitasato University School of Medicine (Japan) |
| Funder | Kitasato University Alumni Association (Japan) - pays incidental costs |
- 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
Scientific
Endocrinology, Diabetes and Metabolism
1-15-1 Kitasato, Minami-ku
Sagamihara
252-0374
Japan
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational longitudinal case-control single-centre study |
| Secondary study design | Case-control study |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
The urinary albumin measured by turbidimetric immunoassay. Measured every 6 months after renal biopsy. |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
252-0374
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
