Sj. Marks et al., THE METABOLIC EFFECTS OF PREFERENTIAL REDUCTION OF VISCERAL ADIPOSE-TISSUE IN ABDOMINALLY OBESE MEN, International journal of obesity, 22(9), 1998, pp. 893-898
SETTING: This study was performed on free living subjects attending th
e body composition laboratory on a monthly basis for a total of six mo
nths. SUBJECTS/DESIGN: Thirty-one abdominally obese men (30 <body mass
index (BMI) <40, waist-to-hip ratio (WHR)>0.95) were enrolled in a pl
acebo-controlled randomized double-blind study, using either dexfenflu
ramine (d-fen) or placebo, whilst also receiving food and fitness coun
selling. After a two week run-in period they were randomized to either
d-fen or placebo for three months. This was followed by a further thr
ee months without medication, although food and fitness counselling co
ntinued. METHODS: Body composition assessment included anthropometry (
weight, height end abdominal circumferences), dual-energy X-ray absorp
tiometry (DEXA) for total body fat, and intra-abdominal fat measured v
ia magnetic resonance imaging (MRI) at the L3/L4 level. Biochemistry i
ncluded serum lipids, insulin and glucose. All measurements including
blood pressure were performed at baseline, three months and six months
. STATISTICAL ANALYSIS: The change within each group in the three mont
hs on medication (d-fen or placebo) was assessed by paired t-tests, wh
ilst the difference between the groups at baseline and at three months
(measured by percentage change from baseline) was assessed by unpaire
d t-tests. An analysis of variance was performed over the six months f
or the d-fen group and the placebo group separately, to determine the
overall effect of three months treatment with either d-fen or placebo,
three months after medication had ceased. OUTCOMES AT THREE MONTHS: A
t three months, BMI decreased by -5.8 +/- 0.8% in the group on d-fen a
nd by -2.7 +/- 0.8% in the placebo group (P<0.01 d-fen vs placebo). Th
ere was also a significant difference in the reduction of the visceral
fat area between the groups (-21.0 +/- 4.0% in the d- fen group vs -6
.7 +/- 2.2% in the placebo group, P<0.01) although there was no signif
icant difference between groups with regard to reduction in subcutaneo
us fat area. The visceral :subcutaneous fat ratio (V/S ratio) was sign
ificantly reduced between groups at three months (-13.3 +/- 4.9% in th
e d-fen group vs -0.7 +/- 3.0% in the placebo group, P = 0.03). At thr
ee months, the only metabolic parameters to show significant differenc
e between the two groups were total cholesterol and LDL cholesterol. T
otal cholesterol reduced by -12.4 +/- 2.0% in the d-fen group compared
with -2.3 +/- 2.1% in the placebo group (P<0.01). LDL cholesterol red
uced by -15.6 +/- 2.6% in the d-fen group compared with -1.2 +/- 2.8%
in the placebo group (P<0.01). OUTCOMES AT SIX MONTHS: In the d-fen gr
oup, the reductions in BMI, abdominal circumference and % total body f
at (DEXA) were sustained after three months on no medication, whereas
all changes in body composition seen in the group on placebo at three
months, had reverted at the three month follow-up. Both groups sustain
ed a reduction in the insulin to glucose (I/G) ratio and systolic and
diastolic blood pressure for three months after medication was ceased,
while those on d-fen initially also maintained a reduction in total a
nd LDL cholesterol.