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Metformin and Core Temperature in Obese and Lean Males

Metformin and Core Temperature in Obese and Lean Males

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02783053
Acronym
McTOM
Enrollment
18
Registered
2016-05-26
Start date
2015-10-31
Completion date
2016-06-30
Last updated
2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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.

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.

Interventions

DRUGMetformin

Metformin vs no metformin

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
18F-FDG uptake1 weekDifference in 18F-FDG uptake as registered by 18F-FDG PET-CT before and after 7 days of daily metformin use.

Secondary

MeasureTime frameDescription
Core temperature using a temperature pill48 hours\- Difference in core body temperature before and after metformin
Correlation core temperature and 18F-FDG uptake1 week\- Correlation between 18F-FDG uptake in the colon and core temperature
Energy expenditure (kcal/day) using ventilated hood30 minutes\- Difference in energy expenditure before and after metformin use
Correlation between 18F-FDG uptake and energy expenditure1 week\- Correlation between difference inenergy expenditure and 18F-FDG uptake in the colon

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026