Status:
UNKNOWN
L-arginine and Brown Adipose Tissue
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Adipose Tissue, Brown
Glucose Intolerance
Eligibility:
MALE
35-50 years
Phase:
PHASE3
Brief Summary
The South Asian population is facing an epidemic of type 2 diabetes, of which the underlying cause is still unknown. It is currently hypothesized that an ethnic susceptibility towards a disturbed ener...
Detailed Description
Rationale: The South Asian population originally descends from the Indian subcontinent and represents approximately 20% of the total world population. This population is facing an epidemic of type 2 d...
Eligibility Criteria
Inclusion
- 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) or Fasting plasma glucose levels \> 5.5 mM
- Good general health
Exclusion
- Type 2 diabetes (determined on basis of oral glucose tolerance test (OGTT))
- 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 (these inhibit BAT activity) \< 1 month before start of study or during study
- 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 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
- 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 behaviour disorders (as judged by the treating medical specialist)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02291458
Start Date
November 1 2014
End Date
December 1 2015
Last Update
November 14 2014
Active Locations (1)
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1
Maastricht University Medical Center +
Maastricht, Limburg, Netherlands, 6229 ER