The effect of the amino acid L-arginine on the function and activity of brown adipose tissue

• Conditions: Obesity, glucose intolerance, endothelial dysfunction; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2014-001733-86-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-06
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Caucasian or South Asian ethnicity
- Age: 35-50 years
- Gender: male
- BMI: 25-30 kg/m2
- Plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance)
- Plasma L-arginine levels 41 – 114 uM (i.e. within healthy range)
- Good general health

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Type 2 diabetes (determined on basis of oral glucose tolerance test)
- BMI > 30 kg/m2
- Plasma glucose levels 2 h after OGTT < 7.8 mM
- Plasma L-arginine levels < 41 or > 114 uM
- Use of beta-blockers < 1 month before start of study or during study
- Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
- Abuse of drugs and/or alcohol
- Hyperthyroidism or hypothyroidism
-Systolic blood pressure < 90 mmHg
-Haematocrit < 0.41 or > 0.51 l/l
-Haemoglobin < 8.5 or > 11.0
-Creatinine (enzymatic method) < 45 or > 100 µmol/L
-ASAT > 45 U/L
-ALAT > 50 U/L
-Alkaline phosphatase > 125 U/L
-Gamma GT > 45 U/L
- Participation in earlier research or medical examinations that included PET-CT scanning
- Psychologically unstable subjects (as judged by the treating medical specialist)
- Subjects with mental retardation (as judged by the treating medical specialist)
- Subjects with severe behavior disorders (as judged by the treating medical specialist)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified