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
Protocol serial number	1
Sponsor	Technical University of Munich (Germany)
Funder	Novartis (International)

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

Nephrology Department
Klinikum rechts der Isar
Ismaninger Strasse 22
Munich
81675
Germany

Study information

Primary study design	Interventional
Study design	Single-centre, open, prospective, longitudinal, non-randmoised controlled trial.
Secondary study design	Non randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	AT1 receptor blocker
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
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 sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan