The effect of L-arginine on brown adipose tissue metabolism in South Asian and white Caucasian subjects

Phase 3

Completed

• Conditions: 10013317; overweight; 10018424

• Registration Number: NL-OMON41875
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-10-25
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

- Caucasians and South Asians 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 > 5.5 mM
- Good general health

Exclusion Criteria

- 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 or Fasting plasma glucose < 5.5 mM
- Use of beta-blockers (these inhibit BAT activity) < 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
- Creatinine (enzymatic method) < 45 or > 100 *mol/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)
- Contra-indications MRI (facultative): presence of metallic objects in which the magnetic field can disrupt its function, including pacemaker, insulin pump, neurostimulator, vascular clips, interior hearing device and artificial cardiac valves. Additionally, we will exclude subjects with metallic residues in the eye (posttraumatic), large tattoos and orthopaedic protheses in the field of the camera.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) glucose uptake by brown adipose tissue<br /><br>2) energy expenditure<br /><br>3) fat mass<br /><br><br /><br><br /><br><br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Thermoregulation (skin temperature, core temperature, skin perfusion and<br /><br>endothelium-dependent and -independent vasodilation) and endothelial function<br /><br>2) Plasma lipids and glucose tolerance<br /><br>3) Systemic inflammation and adipose tissue inflammation<br /><br>4) Insulin signaling in muscle</p><br>