The objective of this study is to investigate what the effects of LCZ696 or amlodipine are on insulin sensitivity as assessed by hyperinsulinemic euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the effects on subcutaneous…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
insulin sensitivity (Hyperinsuline Euglycemische Glucose Clamp (HEGC) )
Secondary outcome
Secundairy reseach variabilities are:
subcutaneous adipose tissue lipolysis (assesed by microdialysis), oxidative
metabolism (assessed by indirect calorimetry) and tolerability of the
medication in obese hypertensive subjects.
Background summary
A lot of people suffer from obesity nowadays. It is known that obesity
increases the possibilities to develop conitions like hypertension, coronary
heart diseases and Diabetes Mellitus type 2 (DM type 2). All these conditions
can have a negative effect on the metabolism.
LCZ696 is a newly developed medicine to treat hypertension and by its specific
mechanisms it does not only lower the blood pressure, but it can also have some
positive influences on the glucose- and fatmetabolism. This may lower the
possibilities of developing coronary heart diseases and DM type 2.
People who suffer from hypertension or heartdiseases could have benificial
effects by the use of LCZ696.
During a treatment period of 8 weeks with LCZ696 or amlodipine, the effects on
insulin sensitivity, subcutaneous adipose tissue lipolysis and oxidative
metabolism will be investigated in obese people with hypertension.
Study objective
The objective of this study is to investigate what the effects of LCZ696 or
amlodipine are on insulin sensitivity as assessed by hyperinsulinemic
euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the
effects on subcutaneous adipose tissue lipolysis (assesed by microdialysis),
oxidative metabolism (assessed by indirect calorimetry) and tolerability of
LCZ696 and amlodipine in obese hypertensive subjects will be measured.
Study design
Randomised, dubbel blind, parallel group intervention study
Intervention
Studiesubjects will be treated with LCZ696 (400 mg QD 1x per day) or amlodipine
(10 mg QD 1x per day) during 8 weeks.
Study burden and risks
After the screening (in which the medical questionnaire will be discussed,
blood and urine will be collected to determine pregnancy, alcohol- and drug
use) the subjects need to come to the university 8 more times during 12 weeks
(total time investment: 24 hours).
During the first visit (1 hour) a general medical examination, a ECG and an
exercise test (on a cycle ergometer) will be taken. During visit 2 and 6 (6
hours), again a general medical examination and a ECG will be taken.
furthermore, the insulin sensitivity will be measured by a Hyperinsulinemic
Euglycemic Glucose Clamp (HEGC). During visit 3 and 7 (4,5 hours) a
microdialysis will be performed together with a indirect calorimetry
measurement and a adipose tissue biopsy will be taken. On visit 4 and 5 (1
hour) and visit 8 (0,5 hour) (control visits), again a general medical
examination and a ECG will be taken. During all visits, the bodylength,
bodyweigth, bloodpressure and hartbeat will be measured and on every visit
there will be taken a bloodsample.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Obese people (>= 18 years old) with mild to moderate essential hypertension with non-childbearing potential
Exclusion criteria
use of other medication, pregnancy, lactating women, history of angioedema, heavy hypertention (grade 3 of the WHO classification)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002606-40-NL |
| ClinicalTrials.gov | NCT01631864 |
| CCMO | NL41639.068.12 |