OBJECTIVE: In obese men, sex hormone-binding globulin (SHBG) as well as total testosterone (TT) levels are decreased. Data concerning serum free testosterone (FT) levels in obese men are discordant. FT levels are decreased in only some morbidly obese men, consistent with an impairment of the feedback regulatory mechanism. In this study we aimed to verify serum levels of TT and FT in two groups of obese men (BMI`35.0 kgam 2 and BMI b 35.1 kgam 2 ) before and after weight loss. DESIGN: Two groups of obese men (group 1: BMI 35 kgam 2 ; and group 2: BMI ! 35.1 kgam 2 ) were studied before and after 6 months of a low energy diet (1200 kcaladay). Every patient received a therapeutic prescription of dexfen¯ur-amine (15 mg b.i.d.) that was maintained for 6 months. SUBJECTS: Thirty-seven obese men and 20 normal weight men. MEASUREMENTS: Serum sex hormones (TT and FT), serum luteinizing hormone (LH) and insulin were analyzed by RIA assays. Plasma insulin levels, serum TT, FT and LH concentrations were obtained before and after weight loss. RESULTS: Moderately obese men (BMI 32.3 AE 1.9 kgam 2 ) presented signi®cantly decreased TT levels (390 AE 120 ngadl) as well as FT (mean AE s.d. : 16.0 AE 4.8 pgaml) as compared with normal controls. FT serum levels had a signi®cant and negative correlation with body mass index (BMI), whereas for TT concentrations this correlation was not signi®cant. Serum LH concentrations (4.5 AE 2.9 mlUaml) were normal. Insulin levels were elevated in all patients (46.3 AE 30.1 m mUaml). After weight loss there was a signi®cant (P`0.01) increase in TT, FT and LH levels, whereas insulin concentrations signi®cantly decreased. In massively obese men (BMI 43.0 AE 6.7 kgam 2 ), TT (320 AE 110 ngadl), FT (11.0 AE 2.1 pgaml) and LH (3.1 AE 1.3 mlUaml) were decreased and signi®cantly lower as compared with the previous group and normal controls. As expected, after weight loss TT, FT and LH levels increased signi®cantly while insulin concentrations decreased. CONCLUSIONS: We concluded that FT levels are dependent on the degree of obesity, massively obese men (BMI ! 35.1 kgam 2 ) being considered as candidates for consistently low FT levels. A functional decrease of LH pulse amplitude and serum LH levels as well as a possible negative action of excess of circulating leptin on the steroidogenesis may be related to the decreased androgens levels in massively obese men.
An ultrasonographic survey of thyroid abnormalities was conducted in 547 consecutive apparently normal overweight subjects (380 females and 167 males), aged 27-58 years in an urban area with relatively low iodine intake (mean daily urinary iodine excretion: 10.6 micrograms/dL). Individuals with any previous thyroid disease or familial thyroid pathology were excluded. In 240 subjects (44%) high resolution ultrasonography of the thyroid was considered normal. In 307 individuals (56%) abnormalities of the echo structure (39%) or thyroid nodular disease (17%) were detected by ultrasonography. Marked heterogeneity of the echo structure that was considered suggestive of chronic autoimmune thyroiditis was present in 81 subjects (15%). In 72 of these patients the serum anti-TPO levels were positive by a sensitive RIA. Thyroid nodules either solid or predominantly cystic were present in 90 subjects (17%). Eighteen patients had a relatively large nodule (diameter 15-18 mm). Eleven of these nodules were missed at clinical examination. Fine needle aspiration cytology was performed in 14 patients and 7 individuals underwent thyroid surgery. In 6 subjects the pathologic diagnosis was benign adenomatous goiter and one patient had a follicular carcinoma. Thyroid function studies confirmed subclinical hypothyroidism in 27 patients (4.9%), all of them with elevated serum anti-TPO autoantibodies levels. It was concluded that the overall occurrence of thyroid disease is more common than suspected by clinical examination.
We prospectively evaluated the effect of thyrotropin (TSH)-suppressive therapy with levothyroxine (LT4) on the size of a benign, solitary, solid nodule and multinodular goiter in a relatively low iodine intake area. In this study, 101 euthyroid subjects with a benign, solitary, predominantly solid nodule (n = 54) confirmed by biopsy or multinodular goiter (n = 47) received 200 microg of levothyroxine daily as a single morning tablet for 12 months. Thirty-five receiving no therapy were considered as controls (solitary nodules, n = 20, multinodular, n = 15). Patients were admitted to the study after evaluation of thyroid biochemical parameters (thyroxine [T4], free thyroxine [FT4], triiodothyronine [T3], thyrotropin [TSH], and thyroglobulin [Tg]), thyroid scanning, ultrasound examination, and fine-needle aspiration biopsy. Every 3 months, thyroid function tests and every 6 months ultrasound examinations were repeated. Twelve months later 20 of 54 (37.1%) patients with single, solid nodules had 50% or more regression of the nodular volume (responders). Eleven of 54 (20.3%) patients had more than 20%, but less than 49.9% reduction of nodular volume (partial responders). Nonresponders were 23 of 54 (42.5%). One-third of subjects with multinodular goiter had 50% or more regression of the glandular volume, whereas 46.8% were considered as nonresponsive. The mean serum Tg levels decreased significantly only in responders with solitary nodular disease or multinodular goiter. In the control group only 1 patient (5% of total) with a solitary nodule had a 50% reduction in the nodular volume. Five others had a partial response (<49%, >20% reduction). None of the patients with multinodular goiter had a significant reduction (>50%) of the combined nodular volumes. We concluded that LT4 may be effective, among other factors, in arresting the growth or in reducing the volume of relatively small, benign, solitary, solid thyroid nodules or the combined nodular volume of multinodular goiter.
OBJECTIVES: This placebo-controlled open study was designed to test the hypothesis that most of the gastrointestinal (GI) side events induced by treatment of obese patients with orlistat (a gastrointestinal lipase inhibitor) could be prevented or ameliorated by concomitant use of natural ®bers (psyllium mucilloid). DESIGN: Two groups of obese women (BMI b 27 kgam 2 ) were treated with orlistat 120 mg three times a day. One group (A, n 30) was randomized to receive orlistat and, approximately 6.0 g of orange-¯avored psyllium mucilloid dissolved in water and the other group (B, n 30) received orlistat and orange-¯avored placebo. At the end of 30 days and 2 weeks of washout, group A switched to placebo and group B received psyllium while continuing orlistat three times a day. SUBJECTS: Sixty professional women, more than 21-y-old with a body mass index (BMI) between 27.3 and 48.0 kgam 2 , who were not receiving any other medication. MEASUREMENTS: Assessments included weekly visits to attending physician, ®lling a form in which GI events were recorded, monthly measurements of body weight, blood pressure and serum lipids. The frequency and severity of GI events were evaluated by a score system, based on information provided by the patients. RESULTS: Both groups A and B signi®cantly lost (P`0.01) weight after 60 days of orlistat (A 96.8 to 94.9 kg and B 98.7 to 96.5 kg). Similarly, BMI values declined signi®cantly in both groups. While in the psyllium plus orlistat group (group A) the mean AE s.e.m. of the scores re¯ecting GI events was 13.0 AE 1.8, the placebo plus orlistat group (B) had a value of 35.9 AE 2.7 (P`0.01). When the reverse situation was instituted the placebo and orlistat group presented a mean score of 36.1 AE 3.6 and the psyllium plus orlistat a mean score of 8.9 AE 1.5 (P`0.01). CONCLUSIONS: Psyllium hydrophilic mucilloid concomitantly prescribed to obese patients receiving 120 mg of orlistat three times a day is an effective and safe adjunct therapy that is helpful in controlling the GI side effects of this pancreatic lipase inhibitor.
Serial weekly serum samples (for 3 weeks) were obtained from 42 patients with differentiated thyroid cancer (DTC, papillary no.=35, follicular no.=6, Hurthle cell no.=1) for serum thyroid hormone, TSH and TG before and after total thyroidectomy. Serum specimens were also obtained one month after radioiodine (131I) therapy followed by suppressive dose of L-thyroxine (L-T4, 2.5 microg/kg). The patients were subdivided into four groups: group I: the DTC was confined to a single solid nodule (no.=1 2); group II: thyroid malignancy invaded local cervical structures but there were no lymph node metastases (no.=8); group III: DTC with lymph node metastases (no.=6); and group IV: DTC with distant metastases (no.=16). In all group I patients serum TG remained undetectable in spite of elevated serum TSH levels at the 3rd week post-surgery (PS). Only one of group II patients had a detectable serum TG value of 5.2 ng/ml (3rd week PS). By contrast, 37.5% of group III patients had detectable serum TG levels, ranging from 3.4 to 16.8 ng/ml (3rd week PS). Lymph node metastases were detected in 5 of these patients by whole body scan (WBS) and removed surgically in 3. As expected, group IV patients had elevated serum TG values ranging 33.0-958.0 ng/ml and distant metastases were confirmed in all of them by WBS. From the calculations through univariate logistic regression comparing TG concentrations at the 3rd week PS from groups I and II vs groups III and IV, we obtained a cut-off value of 2.3 ng/ml with the following efficacy features: sensitivity=74.5%; specificity=95%; positive predictive value=92.3%; negative predictive value=65.5%; and accuracy=73.8%. After 131I and L-T4 suppressive therapy, only 5 out of 36 patients of groups I, II and III had detectable serum TG levels (3.1-7.0 ng/ml) whereas serum TG was detectable in all group IV patients (ranging 2.5-8.6 ng/ml). We concluded that serum TG concentrations above 2.3 ng/ml at the 3rd week PS could be suggestive of lymph node or distant metastases in patients with DTC. Patients with serum TG above this limit could be considered at risk for metastatic disease and higher doses of diagnostic iodine-131 (131I) may be indicated for actinic ablation.
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