Trial Outcomes & Findings for Effects of Metformin on Hepatic FFA Metabolism (NCT NCT01729156)
NCT ID: NCT01729156
Last Updated: 2019-10-15
Results Overview
Hepatic fatty acid oxidation assessed by dynamic C11-palmitate PET
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
90 days
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy Controls
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Metformin on Hepatic FFA Metabolism
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=12 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=12 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=12 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 6 • n=93 Participants
|
60 years
STANDARD_DEVIATION 5 • n=4 Participants
|
64 years
STANDARD_DEVIATION 5 • n=27 Participants
|
62 years
STANDARD_DEVIATION 5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
BMI
|
27.3 kg/m2
STANDARD_DEVIATION 4.1 • n=93 Participants
|
31.2 kg/m2
STANDARD_DEVIATION 4.3 • n=4 Participants
|
30.3 kg/m2
STANDARD_DEVIATION 5.7 • n=27 Participants
|
29.6 kg/m2
STANDARD_DEVIATION 4.7 • n=483 Participants
|
|
HbA1C
|
37 mmol/mmol
STANDARD_DEVIATION 3 • n=93 Participants
|
45 mmol/mmol
STANDARD_DEVIATION 6 • n=4 Participants
|
51 mmol/mmol
STANDARD_DEVIATION 6 • n=27 Participants
|
44 mmol/mmol
STANDARD_DEVIATION 5 • n=483 Participants
|
PRIMARY outcome
Timeframe: 90 daysHepatic fatty acid oxidation assessed by dynamic C11-palmitate PET
Outcome measures
| Measure |
Healthy Controls
n=10 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=11 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=10 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Hepatic Fatty Acid Oxidation
|
0.052 micromol/ml/min
Standard Deviation 0.024
|
0.045 micromol/ml/min
Standard Deviation 0.024
|
0.042 micromol/ml/min
Standard Deviation 0.017
|
PRIMARY outcome
Timeframe: 90 daysHepatic fatty acid reesterification assessed by C11-palmitate PET
Outcome measures
| Measure |
Healthy Controls
n=10 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=11 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=10 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Hepatic Fatty Acid Reesterification
|
0.134 micromol/ml/min
Standard Deviation 0.056
|
0.091 micromol/ml/min
Standard Deviation 0.035
|
0.113 micromol/ml/min
Standard Deviation 0.025
|
PRIMARY outcome
Timeframe: 90 daysHepatic fatty acid uptake assessed by C11-palmitate PET
Outcome measures
| Measure |
Healthy Controls
n=10 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=11 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=10 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Hepatic Fatty Acid Uptake
|
0.186 micromol/ml/min
Standard Deviation 0.067
|
0.137 micromol/ml/min
Standard Deviation 0.051
|
0.155 micromol/ml/min
Standard Deviation 0.029
|
PRIMARY outcome
Timeframe: 90 daysHepatic VLDL-TG secretion assessed by \[1-14C\] VLDL tracer
Outcome measures
| Measure |
Healthy Controls
n=11 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=11 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=11 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
VLDL-TG Secretion
|
48 micromol/min
Standard Deviation 30
|
83 micromol/min
Standard Deviation 49
|
71 micromol/min
Standard Deviation 31
|
PRIMARY outcome
Timeframe: 90 daysWhole body basal glucose metabolism assessed by \[3-3H\]glucose tracer kinetics
Outcome measures
| Measure |
Healthy Controls
n=11 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=12 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=11 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Whole Body Glucose Rd
|
1.74 mg/kg/min
Standard Deviation 0.29
|
1.30 mg/kg/min
Standard Deviation 0.31
|
1.78 mg/kg/min
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 90 daysFatty acid turnover assessed as whole body C11-palmitate turnover
Outcome measures
| Measure |
Healthy Controls
n=10 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=11 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=11 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Fatty Acid Turnover
|
464 micromol/min
Standard Deviation 127
|
476 micromol/min
Standard Deviation 149
|
559 micromol/min
Standard Deviation 295
|
SECONDARY outcome
Timeframe: 90 daysVLDL-TG oxidation assessed by 14C carbon dioxide (CO2) in exhaled breath
Outcome measures
| Measure |
Healthy Controls
n=11 Participants
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=12 Participants
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=11 Participants
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
VLDL-TG Oxidation
|
29 percentage of 14C-VLDL
Standard Deviation 5
|
30 percentage of 14C-VLDL
Standard Deviation 7
|
27 percentage of 14C-VLDL
Standard Deviation 9
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Controls
n=12 participants at risk
Healthy controls receiving 1000 mg metformin twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
Placebo
n=12 participants at risk
Placebo
Placebo: 2 tablets twice daily in 3 months
|
Metformin
n=12 participants at risk
Metformin "Teva", 1000 mg twice daily for 3 months
Metformin: 1000 mg metformin twice daily in 3 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal uncomfort
|
8.3%
1/12 • Number of events 1 • During the 90 days trial
|
0.00%
0/12 • During the 90 days trial
|
0.00%
0/12 • During the 90 days trial
|
|
Musculoskeletal and connective tissue disorders
Fractured vertebral column
|
0.00%
0/12 • During the 90 days trial
|
8.3%
1/12 • Number of events 1 • During the 90 days trial
|
0.00%
0/12 • During the 90 days trial
|
Additional Information
Lars C. Gormsen, Consultant
Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
Phone: 004578456260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place