Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
IGT-FRA-oo30-I
Study hypothesis
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
The study was approved by the Ethical Committee of the Technical University of Munich.
Study design
Single-centre, open, prospective, longitudinal, non-randmoised controlled trial.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
26/07/2005
Overall trial end date
20/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
24
Participant exclusion criteria
1. Renal or liver insufficiency
2. Micro-or macro-albuminuria
3. Overt diabetes mellitus
Recruitment start date
26/07/2005
Recruitment end date
20/10/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Nephrology Department
Munich
81675
Germany
Sponsor information
Organisation
Technical University of Munich (Germany)
Sponsor details
Ismaninger Strasse 22
Munich
81675
Germany
+49 89 4140 2231
Helga.Frank@lrz.tum.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Novartis (International)
Alternative name(s)
Novartis AG, Novartis International AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
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
Basic results (scientific)
Publication list