Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/12/2007
Date assigned
09/01/2008
Last edited
29/02/2008
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 Helga Frank

ORCID ID

Contact details

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

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 measures

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

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)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes