Metformin and Core Temperature in Obese and Lean Males

Obesity Clinical Trial

— McTOM  

Official title:

Metformin and Core Temperature in Obese and Lean Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783053
• Other study ID #: METC2015_117
• Status: Completed
• Phase: N/A
• First received: October 19, 2015
• Last updated: October 7, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective trials.

In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

Description:

Obesity and diabetes mellitus type 2 (DM2) are health problems with a tremendous impact. Many attempts have been made to combat obesity and DM2, however, a breakthrough therapy is still lacking.

Obesity is the result of an imbalance between energy intake and energy expenditure. 18F-fluorodeoxy-d-glucose (18F-FDG) positron emission tomography computed tomography (PET-CT) pinpoint areas with high glucose turnover. Physiological 18F-FDG accumulation is frequently observed in the colon. Therefore, the colon might play an important role in increasing energy expenditure by consuming calories. However, the possibility of the colon as an energy dissipating tissue has not yet been explored. The colon could become an interesting new target of research to find a method to combat obesity.

Metformin is one of the few drugs in the treatment of DM2 that is associated with moderate weight loss. Interestingly, patients using metformin show an increased 18F-FDG-uptake in the colon. Whether this higher uptake of glucose also cause an increase in core temperature and/or an increase in energy expenditure is not known. The cause for this increase in glucose uptake in the colon by metformin use is unknown. Also, it is unknown whether this increase in glucose uptake results in an increased energy expenditure and/or an increase in core body temperature.

Objective: In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male

• Caucasian origin

• Subjects should be able and willing to give informed consent

• > 50 years old

• BMI< 24 kg/m2 or > 28 kg/m2

Exclusion Criteria:

• Renal failure (GFR< 60ml/min)

• Liver insufficiency (AST or alanine aminotransferase 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Metformin
Metformin vs no metformin

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-FDG uptake	Difference in 18F-FDG uptake as registered by 18F-FDG PET-CT before and after 7 days of daily metformin use.	1 week	No
Secondary	Core temperature using a temperature pill	- Difference in core body temperature before and after metformin	48 hours	No
Secondary	Correlation core temperature and 18F-FDG uptake	- Correlation between 18F-FDG uptake in the colon and core temperature	1 week	No
Secondary	Energy expenditure (kcal/day) using ventilated hood	- Difference in energy expenditure before and after metformin use	30 minutes	No
Secondary	Correlation between 18F-FDG uptake and energy expenditure	- Correlation between difference inenergy expenditure and 18F-FDG uptake in the colon	1 week	No