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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Metformin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Metformin use; The investigators compare the use of metformin vs no metformin	Drug: Metformin; Metformin vs no metformin
No Intervention: Lean or Obese; The investigators compare the effect of metformin on 18F-FDG uptake between lean and obese men.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core temperature using a temperature pill	- Difference in core body temperature before and after metformin	48 hours
Correlation core temperature and 18F-FDG uptake	- Correlation between 18F-FDG uptake in the colon and core temperature	1 week
Energy expenditure (kcal/day) using ventilated hood	- Difference in energy expenditure before and after metformin use	30 minutes
Correlation between 18F-FDG uptake and energy expenditure	- Correlation between difference inenergy expenditure and 18F-FDG uptake in the colon	1 week

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: METC2015_117