The effect of experimental hyperglycemia and AT1 receptor blockade on renal hemodynamics in impaired glucose tolerance
| ISRCTN | ISRCTN07427212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07427212 |
| Secondary identifying numbers | 1 |
- Submission date
- 21/12/2007
- Registration date
- 09/01/2008
- Last edited
- 29/02/2008
- 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 Helga Frank
Scientific
Scientific
Nephrology Department
Klinikum rechts der Isar
Ismaninger Strasse 22
Munich
81675
Germany
Study information
| Study design | Single-centre, open, prospective, longitudinal, non-randmoised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | IGT-FRA-oo30-I |
| Study objectives | The study aim is to investigate whether: 1. Experimental hyperglycemia reduces renal hemodynamics (glomerula filtration rate, renal plasma flow) 2. Angiotensin II Type 1 (AT1) receptor blocker treatment prevents hyperglycemia induced changes of renal hemodynamics |
| Ethics approval(s) | The study was approved by the Ethical Committee of the Technical University of Munich. |
| Health condition(s) or problem(s) studied | Impaired glucose tolerance/ renal changes in prediabetes |
| Intervention | 12 participants were recruited in each of the two groups. Statistical calculation was carried out by the Institute of Statistics, Technical University of Munich. Participants of both groups (control and IGT-group) received the following two interventions: 1. Experimental hyperglycemia (clamp technique) 2. Valsartan (AT1 receptor blocker)(oral, taken once a day in the morning) treatment for 4 weeks. The initial dose was 80 mg/day, and the dosage was increased after 7 +/- 2 days of administration to 160 mg /day. A safety visit was made at 5 +/- 2 days after the beginning of the study for the measurement of serum creatintine, potassium and blood pressure. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | AT1 receptor blocker |
| Primary outcome measure | The following were measured at rest (U1 rest, U2 rest) and during hyperglycemic stress testing (U1 stress, U2 stress) with and without AT1 receptor blocker treatment: 1. Glomerular filtration rate (inulin clearance) 2. Renal plasma flow (Para-AminoHippurate [PAH] clearance) U1: Without AT1 receptor blocker U2: After a 4-week treatment with valsartan |
| Secondary outcome measures | The following were assessed at U1 and U2: 1. High-sensitivity C-Reactive Protein (CRP) 2. Adiponectin 3. HbA1c (blood tests) U1: Without AT1 receptor blocker U2: After a 4-week treatment with valsartan |
| Overall study start date | 26/07/2005 |
| Completion date | 20/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Males 2. 18-70 years old 3. Impaired Glucose Tolerance (for the intervention group [IGT-Group]) (tested by the oral glucose tolerance test according to the World Health Organisation) and normoglycemic patients (for control group [healthy subjects]) |
| Key exclusion criteria | 1. Renal or liver insufficiency 2. Micro-or macro-albuminuria 3. Overt diabetes mellitus |
| Date of first enrolment | 26/07/2005 |
| Date of final enrolment | 20/10/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Nephrology Department
Munich
81675
Germany
81675
Germany
Sponsor information
Technical University of Munich (Germany)
University/education
University/education
Ismaninger Strasse 22
Munich
81675
Germany
| Phone | +49 89 4140 2231 |
|---|---|
| Helga.Frank@lrz.tum.de | |
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
Industry
Novartis (International)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Novartis AG, Novartis International AG
- Location
- Switzerland
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 |
