Abstract:To assess the biological activity and tolerability of pegylated recombinant native human leptin (PEG-OB), 30 obese men (mean body mass index, 33.9 kg/m2) were randomized to a double-blind treatment with weekly sc injections of 20 mg PEG-OB or placebo for 12 weeks, in addition to a hypocaloric diet (deficit, 2 MJ/day). Body composition, energy expenditure, and metabolic parameters were measured before and after treatment. PEG-OB was generally well tolerated based on adverse event reports, lab values, and vital … Show more
“…However, this is in agreement with other clinical trials demonstrating that leptin is not an effective weight loss agent for obese individuals without congenital leptin deficiency (8,13). Studies reported thus far have seen little change in total fat mass with leptin treatment, which is in agreement with our results (8,14). To our knowledge this is the first trial to examine effects of leptin administration specifically on visceral fat mass.…”
Results: Groups treated with CE and LCE lost significant amounts of weight (À5.9 6 1.2% and À6.5 6 1.1%, P < 0.05) and whole body fat mass (À9.6 6 2.4% and À12.4 6 2.3%, P < 0.05) compared to leptin only group. Only treatment with LCE significantly reduced visceral fat mass (À11.0 6 3.3%, P < 0.05). There were no differences in lean mass between treatment groups. Conclusions: Our study provides evidence that CE is a modestly effective weight loss agent and produces significant reductions in fat mass. Leptin A-200 was not effective in producing weight loss and did not have any significant additive or synergistic actions when combined with CE.
“…However, this is in agreement with other clinical trials demonstrating that leptin is not an effective weight loss agent for obese individuals without congenital leptin deficiency (8,13). Studies reported thus far have seen little change in total fat mass with leptin treatment, which is in agreement with our results (8,14). To our knowledge this is the first trial to examine effects of leptin administration specifically on visceral fat mass.…”
Results: Groups treated with CE and LCE lost significant amounts of weight (À5.9 6 1.2% and À6.5 6 1.1%, P < 0.05) and whole body fat mass (À9.6 6 2.4% and À12.4 6 2.3%, P < 0.05) compared to leptin only group. Only treatment with LCE significantly reduced visceral fat mass (À11.0 6 3.3%, P < 0.05). There were no differences in lean mass between treatment groups. Conclusions: Our study provides evidence that CE is a modestly effective weight loss agent and produces significant reductions in fat mass. Leptin A-200 was not effective in producing weight loss and did not have any significant additive or synergistic actions when combined with CE.
“…Additionally, the present findings may offer an explanation for the disappointing results in clinical trials with recombinant human leptin administration, which alone, provides little benefit in obesity treatment. 52 …”
OBJECTIVES:To investigate whether moderate physical activity or snack intake influence appetite sensations and subsequent food intake in obese women. Associations between serum leptin and appetite ratings were also investigated. METHODS: In all, 10 obese women (mean age7s.d.: 50.078.5 y; mean body mass index (BMI)7s.d.: 37.276.5 kg m À2 ) were submitted in random order to three trials: Moderate physical activity (20 min brisk walking), Snack (58.5 g chocolatebased) and Control (sitting, TV-watching). Appetite and satiety were assessed by visual analogue scales, and serum leptin, blood glucose and plasma free fatty acids were measured at baseline, pre-and postintervention and 1 h postintervention (ie, before dinner). A buffet-style dinner was provided subsequent to the three trials. RESULTS: The moderate physical activity and snack intake both produced lower appetite and higher satiety and fullness perceptions, compared to control, following the intervention. No significant differences were found in subsequent food intake. Serum leptin concentrations did not differ between trials. Serum leptin was not associated with appetite or satiety sensations at any time during the control or the snack trials, but was correlated following moderate physical activity (prospective food consumption r s ¼ À0.83, P ¼ 0.003; hunger r s ¼ À0.79, P ¼ 0.007; desire to eat r s ¼ À0.69, P ¼ 0.02; satiety r s ¼ 0.71, P ¼ 0.02; fullness r s ¼ 0.66, P ¼ 0.04). These associations were not influenced by BMI or fat mass. CONCLUSIONS: Moderate physical activity and snack intake suppress the appetite of obese women acutely. The associations between circulating leptin and appetite-satiety ratings suggest leptin involvement in short-term appetite regulation in response to physical activity-induced factors.
“…Serum leptin concentrations were measured according to the method described previously. 33 Attitude towards eating. Attitude towards eating was characterized using a Dutch translation of the TFEQ.…”
OBJECTIVE:To examine the effect of dietary restraint during and following pegylated recombinant leptin (PEG-OB protein) treatment in overweight men. DESIGN: A randomized double-blind placebo-controlled trial in 24 overweight men (BMI: 28.870.3 kg/m 2 ; age: 34.870.9 y). PEG-OB protein (80 mg) or placebo was administered subcutaneously weekly for 6 weeks, combined with a 2.1 MJ/day energy restriction program. Dietary restraint was determined by the Three-Factor Eating Questionnaire before and after treatment, and after 8 weeks follow-up. RESULTS: During treatment dietary restraint increased, and general hunger, resting energy expenditure and respiratory quotient decreased similarly in the PEG-OB and the placebo group. With PEG-OB treatment, additional weight loss (Po0.03) was observed. During 8 weeks follow-up, body weight increase was larger in the PEG-OB group compared to placebo (Po0.05), and body weight regain was faster. Body weight regain was inversely correlated with the increase in cognitive dietary restraint during treatment (PEG-OB group: r 2 ¼ 0.49, Po0.02; placebo group: r 2 ¼ 0.60, P ¼ 0.01). CONCLUSION: Although treatment with PEG-OB protein led to a greater body weight loss relative to placebo, weight maintenance thereafter was mainly supported by dietary restraint, which was more effective in the placebo-treated group, resulting in a slower regain of body weight.
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