3017
document
Treatment with metformin of non-diabetic men with hypertension , hypertriglyceridaemia and central fat distribution : the BIGPRO 1.2 trial . BACKGROUND In the BIGPRO 1 trial , one year of treatment with metformin in non-diabetic obese subjects with a central fat distribution had no significant effect on fasting plasma triglyceride concentration or on blood pressure despite a decrease in weight , fasting plasma insulin and glucose concentrations . To re-evaluate the effect of metformin on fasting triglyceride concentration and on blood pressure , the BIGPRO 1.2 trial included non-diabetic men ( n=168 ) with a fasting plasma triglyceride concentration > or =1.7 and < or =6.5 mmol/l , high blood pressure ( systolic > or =140 and < or =180 and/or diastolic > or =90 and < or =105 mmHg , or treatment for hypertension ) and a waist-to-hip ratio > or =0.95 . METHODS A randomised double-blind trial comparing metformin treatment ( 850 mg bid ) with placebo . RESULTS Metformin had no significant effect either on blood pressure or plasma triglyceride concentration . In comparison with the placebo group , fasting plasma insulin ( p < 0.04 ) , total cholesterol ( p < 0.05 ) and Apo B ( p < 0.008 ) concentrations decreased more in the metformin group in the BIGPRO 1 . 2 trial , confirming most of the previous results of the BIGPRO 1 trial . Tissue plasminogen activator antigen concentration decreased significantly ( p < 0.01 ) only in the metformin group , but this was not significantly different from the placebo group ( p < 0.12 ) ; further , there were no significant differences in the change in plasminogen activator inhibitor 1 . CONCLUSIONS The consistency of the two BIGPRO trials supports the conclusion that metformin affects several cardiovascular risk factors favourably in non-diabetic subjects with a central fat distribution .
3018
Intervention_Pharmacological
metformin
3019
Intervention_Pharmacological
metformin
3020
Intervention_Pharmacological
metformin
3021
Intervention_Pharmacological
metformin
3022
Intervention_Control
placebo
3023
Intervention_Pharmacological
Metformin
3024
Intervention_Control
placebo
3025
Intervention_Pharmacological
metformin
3026
Intervention_Control
placebo
3027
Intervention_Pharmacological
metformin
3028
Outcome_Physical
blood pressure or plasma triglyceride concentration .
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Outcome_Physical
fasting plasma insulin
3030
Outcome_Physical
total cholesterol
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Outcome_Physical
Apo B
3032
Outcome_Physical
concentrations
3033
Outcome_Physical
Tissue plasminogen activator antigen concentration
3034
Participant_Condition
non-diabetic
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Participant_Condition
hypertension , hypertriglyceridaemia and central fat distribution
3036
Participant_Condition
non-diabetic obese subjects with a central fat distribution
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Participant_Condition
non-diabetic
3038
Participant_Sex
men
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Participant_Sample-size
n=168
3040
Participant_Condition
fasting plasma triglyceride concentration > or =1.7 and < or =6.5 mmol/l , high blood pressure ( systolic > or =140 and < or =180 and/or diastolic > or =90 and < or =105 mmHg
3041
Participant_Condition
treatment for hypertension
3042
Participant_Condition
a waist-to-hip ratio > or =0.95 .
3043
Participant_Condition
non-diabetic subjects with a central fat distribution