Metformin and Core Temperature in Obese and lean Males (McTOM)

Completed

• Conditions: Energy disposal; energy dissipating organ; 10018424

• Registration Number: NL-OMON42453
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- > 50 years old
- BMI> 28 kg/m2 or BMI < 24 kg/m2

Exclusion Criteria

- Renal failure (GFR< 60ml/min)
- Liver insufficiency (AST or ALT 3 times upper value)
- Chronic use of drugs or medication
- Diabetes mellitus
- Lactate acidosis or precoma diabeticum in medical history
- Acute or chronic diseases such as: dehydration, severe infection, shock, heartfailure, pulmonary insufficiency, recent heart attack
- Alcoholism

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in 18F-FDG uptake as registered by 18F-FDG PET-CT before and after 7<br /><br>days of daily metformin use</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Difference in core body temperature before and after metformin use and the<br /><br>correlation with 18F-FDG uptake<br /><br>- Difference in energy expenditure before and after metformin use and the<br /><br>correlation with 18F-FDG uptake.<br /><br>- Correlation between difference in core temperature and respectively 18F-FDG<br /><br>uptake and energy expenditure, before, after 7 days of daily metformin use.<br /><br>- Difference in lactate, before and after the use of metformin and the<br /><br>correlation between lactate and respectively 18F-FDG uptake, core body<br /><br>temperature and energy expenditure. </p><br>