MedPath

Targeting the beta-2 adrenergic pathway to improve skeletal muscle glucose uptake in obese humans

Phase 2
Completed
Conditions
diabetes
Type 2 diabetes mellitus
10018424
Registration Number
NL-OMON51975
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

1. Male or (postmenopausal; defined as 1 year after the last cycle) female;
2. Age between 40-75 years;
3. BMI: 25-35 kg/m2;

Exclusion Criteria

1. Not meeting all inclusion criteria
2. Cardiovascular disease (determined by means of questionnaires, heart
rate/blood pressure measurements and an ECG)
3. Respiratory diseases (including asthma, bronchitis and COPD);
4. Unstable body weight (weight gain or loss > 5 kg in the last three months);
5. Intention to lose or gain body weight (e.g. with caloric restriction or
physical activity)
6. Excessive alcohol and/or drug abuse;
7. Hypokalaemia;
8. Hyperthyroidism
9. Anaemia;
10. Epilepsy;
11. Smoking;
12. Renal and/or liver insufficiency;
13. Diagnosed with type 1 or type 2 diabetes mellitus;
14. Any contra-indications to MRI scanning. These contra-indications include
patients with:
a. Electronic implants such as pacemakers, defibrillators or neurostimulators
b. Central nervous system aneurysm clip
c. Some hearing aids (such as cochlear implant) and artificial (heart) valves
which are contraindicated for MRI/MRS
d. Iron containing corpora aliena in the eye or brains
e. Claustrophobia
15. Participation in another biomedical study within 1 month before the first
study visit, possibly interfering with the study results;
16. Medication use known to hamper subject*s safety during the study
procedures; *
17. Subjects who do not want to be informed about unexpected medical findings; *
18. Subjects who do not want that their treating physician to be informed;
19. Inability to participate and/or complete the required measurements;
20. Participation in organised or structured physical exercise;
21. Any condition, disease or abnormal laboratory test result that, in the
opinion of the Investigator, would interfere with the study outcome, affect
trial participation or put the subject at undue risk;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameter is insulin-stimulated 18F-FDG uptake in quadriceps muscle<br /><br>as assessed using radio-active labelled tracer in PET-MRI</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary outcome parameter is insulin-stimulated 18F-FDG uptake in BAT as<br /><br>assessed using radio-active labelled tracer in PET-MRI.</p><br>
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