Metformin and Core Temperature in Obese and Lean Males
McTOM
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 10, 2016
October 1, 2016
8 months
October 19, 2015
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Core temperature using a temperature pill
48 hours
Correlation core temperature and 18F-FDG uptake
1 week
Energy expenditure (kcal/day) using ventilated hood
30 minutes
Correlation between 18F-FDG uptake and energy expenditure
1 week
Study Arms (2)
Metformin use
OTHERThe investigators compare the use of metformin vs no metformin
Lean or Obese
NO INTERVENTIONThe investigators compare the effect of metformin on 18F-FDG uptake between lean and obese men.
Interventions
Eligibility Criteria
You may qualify if:
- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- \> 50 years old
- BMI\< 24 kg/m2 or \> 28 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, 1105AZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 19, 2015
First Posted
May 26, 2016
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10