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Context Hormone administration to elderly individuals can increase lean body mass LBM and decrease fat, but interactive effects of growth hormone GH and sex steroids and their influence on strength and endurance are unknown. Main Outcome Measures Lean body mass, fat mass, muscle strength, maximum oxygen uptake O 2 Wife seeking sex Harman during treadmill test, and adverse effects. In women, LBM increased by 0. In men, LBM increased by 0. Men's strength also did not increase ificantly except for a marginally ificant increase of Women's O 2 max declined by 0.

Men's O 2 max declined by 1. Conclusions In this study, GH with or without sex steroids in healthy, aged women and men increased LBM and decreased fat mass. Because adverse effects were frequent importantly, diabetes and glucose intoleranceGH interventions in the elderly should be confined to controlled studies. The extent to which reduced function of the growth hormone GH and insulinlike growth factor I IGF-I axis in aged women and men, 12 estrogen deficiency in postmenopausal women, 3 and decreases in testosterone 4 in older men contribute to decrements in skeletal muscle mass and strength 5 and increases in total and intra-abdominal fat 6 remains uncertain.

The latter may be precursors of clinical conditions such as musculoskeletal frailty with reduced physical function, 7 insulin resistance, type 2 diabetes, and cardiovascular disease. In nonelderly GH-deficient adults, sarcopenia, central obesity, and other features resembling the aging phenotype are improved by long-term hormone replacement with recombinant human GH rhGH. Subsequent studies have confirmed that short-term GH replacement in older persons improves body composition, 2 but studies have not demonstrated gains in muscle strength or cardiovascular endurance.

In older adults GH administration commonly produces adverse effects, including carpal tunnel syndrome, peripheral edema, arthralgias, and glucose intolerance. Despite the paucity of efficacy and safety data, there is extensive off-label prescription of GH for healthy older persons to reverse effects of the "somatopause," 13 with little emphasis given to actual and potential adverse effects. Hormone replacement therapy HRT in Wife seeking sex Harman postmenopausal women decreases abdominal visceral fat and improves plasma lipid profiles.

Changes in body composition and function during aging may result in part from the interactive effects of decreases in both GH and sex steroids. We evaluated the effects of 26 weeks of rhGH and gonadal steroid administration, alone and in combination, on body composition, muscle strength, cardiovascular endurance, and adverse effects in healthy older women and men.

Ambulatory, community-dwelling US women and men, ranging in age from 65 to 88 years, were recruited by mailings and advertisements between June and July All were healthy as verified by screening history and physical examination, routine blood studies, and urinalysis.

No participant had diabetes, depression, untreated thyroid disease, symptomatic or occult CAD demonstrated by graded treadmill exercise test, liver or renal disease, or cancer other than basal cell skin cancer. No man had ly taken testosterone replacement. Written informed consent was obtained from each participant. There was no stratification or blocking. Height was measured using a standing stadiometer and weight with a calibrated clinical scale.

At 8 AM on day 2, after an overnight fast, blood was collected for measurements of serum IGF-I, E 2 in Wife seeking sex Harman to confirm menopauseand testosterone in men. On days 2 and 3, the primary outcome measurements of muscle strength, O 2 max, and body composition were assessed as described below.

Participants were instructed in Wife seeking sex Harman of study medications and discharged on the afternoon of day 3. Participants were advised to maintain their usual level of physical activity and to consume their customary diets during the week protocol. Physical activity patterns were assessed using the Physical Activity Scale for the Elderly PASE22 and 3-day diet histories were obtained by a nutritionist. At week 26, all baseline procedures were repeated. A nurse not involved in assessment of end points or adverse effects administered testosterone to men as biweekly intramuscular injections of mg of testosterone enanthate in oil Delatestryl Injection; Bio-Technology General Corp, Iselin, NJ or the same volume of sterile saline placebo.

All participants self-administered GH or placebo injections 3 times per week Monday, Wednesday, and Friday 1 hour before bedtime. Serum levels of E 2 and testosterone were measured in duplicate by radioimmunoassay using commercial kits Diagnostic Products Corporation, Los Angeles, Wife seeking sex Harman. Interassay coefficients of variation were 9. Total body scans were analyzed using Lunar software version 3. The scanner was calibrated daily according to the manufacturer's recommendations. Muscle strength was assessed by a standard 1-repetition maximum 1-RM procedure 25 using 4 upper body bench press, upright row, arm curl, and arm extension and 2 lower body leg press and leg curl stations on an exercise machine Universal Fitness, West Point, Miss.

Participants were familiarized with each exercise by performing several repetitions using unloaded equipment, after which a 1-RM weight was estimated by adding 2. The highest weight lifted was the 1-RM. Participants rested as needed between attempts and were monitored continuously with electrocardiography ECG.

Most individuals reached 1-RM in 3 to 4 attempts so that progressive fatigue was not a confounding factor. Total body strength was calculated as the sum of all 6 1-RM values. Cardiovascular endurance maximum aerobic capacity [O 2 max] was assessed as maximum oxygen uptake during a symptom-limited graded treadmill test using a modified Bruce protocol.

Maximal oxygen uptake, ventilation, CO 2 production, and anaerobic threshold were determined using a commercial metabolic analysis system Medical Graphics CardiO 2, St Paul, Minn. Data were expressed as milliliter of oxygen consumed per kilogram of body weight. Participants were seen weekly for assessment of adverse effects and measurement of body weight, temperature, blood pressure, and pulse.

Every 4 weeks the same physician or nurse practitioner conducted a detailed assessment including a structured questionnaire seeking symptoms of carpal tunnel Wife seeking sex Harman, t pain, and headaches or visual changes and a physical examination assessing the optic fundi, peripheral sensation in the hands, t swelling or tenderness, and dependent edema. For Wife seeking sex Harman purposes, we defined edema as swelling of a lower extremity, with evident pitting on moderate digital pressure, with or without symptoms; carpal tunnel symptoms as complaints of numbness or paresthesia of hands on more than 2 occasions with no precipitating event; and arthralgia as new or increased t pain, stiffness, or tenderness.

Blood was collected after an overnight fast for serum glucose, IGF-I, testosterone 1 week after most recent biweekly injectionE 2and hematocrit determinations. Glucose intolerance and diabetes were defined using revised American Diabetes Association criteria. For each dose reduction, a similar reduction was instituted for a participant taking the corresponding placebo.

Men also completed a prostate symptom questionnaire International Prostate Symptom Scale. Data were analyzed using SAS statistical software versions 6. All data are expressed as the mean SE values. Primary analyses were by intention to treat, carrying forward the last recorded data points for each variable from the 6 individuals 4. Sex differences for each variable at baseline or after 26 weeks were assessed by 1-way analysis of variance. ificance of changes week minus baseline values in LBM, total body fat, muscle strength, and O 2 max were calculated by 1-way analysis of covariance adjusted for age, value of the dependent variable at baseline, and treatment group.

Each treatment group was compared with the placebo group; the method of Dunnett 29 was used to control for multiple comparisons.

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Separate models were analyzed for men and women. To investigate relationships between hormones and other outcome measures we calculated Pearson correlation coefficients between variables at baseline and, in separate analyses, between changes in variables. Relationships were assessed in women and men together when slopes of regressions in each sex showed no ificant differences.

Adverse event frequencies were compared between treatment and placebo groups separately for women and men by Fisher exact test in all participants randomized. The study population Wife seeking sex Harman 57 women and 74 men aged 65 through 88 years mean [SE], 72 [0.

Four women and 2 men discontinued before 26 weeks dropout rate, 4. Mean baseline ages did not differ by sex, but weight, body mass index, and IGF-I levels were higher in men Table 1. Within-sex group characteristics did not differ ificantly Table 1. Three-day diet histories and self-reported physical activity PASE did not differ before or after treatment in either sex data Wife seeking sex Harman shown.

Neither placebo nor GH treatment ificantly changed sex steroid levels in either sex Figure 2 C and 2D. In a secondary "as-treated" analysis of individuals completing 26 weeks, LBM increased ificantly with testosterone by 2.

At baseline, there were no ificant within-sex group differences in fat mass. In women O 2 max did not increase, whereas it increased by 8. These baseline and posttreatment relationships were similar in women and men, with no ificant sex differences in slopes of corresponding regression equations data not shown. In men, baseline and posttreatment relationships of testosterone with LBM, fat mass, strength, or O 2 max were not ificant data not shown.

Edema and arthralgias were more common in GH-treated women. Testosterone administration did not ificantly increase these adverse effects. Weight changes of more than 3 kg or changes in mean body weight did not differ ificantly in any treatment group data not shown.

Occurrence of these adverse effects was similarly correlated with the maximum level of IGF-I and ificantly but less strongly with changes in IGF-I levels data not shown. There were no ificant increases in the incidence of headaches or changes in the optic fundi. In men there were no ificant increases in gynecomastia Table 5symptoms of prostatism, or excessive daytime sleepiness.

One woman placebo group had a basal cell skin cancer and 1 man testosterone group was diagnosed as having a dysplastic junctional nevus, which were resected surgically. Systolic and diastolic blood pressures and mean pulse rates did not change ificantly in any treatment group data not shown. As illustrated in Table 6at baseline none of the women or men met the revised 27 ADA criteria for diabetes mellitus, but 3 men did so for fasting glucose intolerance. Sex steroid administration did not increase rates of fasting glucose intolerance or diabetes in women or men.

Fasting glucose returned to normal values 2 to 6 weeks after discontinuation of treatment in diabetic men. In men, there were no ificant increases in hematocrit in any hormone-treated group. In men receiving testosterone, there were no ificant relationships between maximum value or maximum change in hematocrit and measures of testosterone data not shown.

Mean serum PSA levels did not change ificantly in any treatment group data not shown. After testosterone administration, 2 men exhibited increases in PSA greater than 1. There were Wife seeking sex Harman ificant changes in International Prostate Symptom Scale scores or increased complaints of prostatism symptoms in any group.

Changes in muscle strength and O 2 max were directly related to changes in LBM. To our knowledge, these findings are novel. Data from prior studies 2135 suggest that the age-related decline in testosterone in men contributes to reduction in GH secretion and that the latter can be partially reversed Wife seeking sex Harman testosterone in doses higher than those we used. Growth hormone alone did not ificantly alter sex steroids in either sex, suggesting that the GH doses used did not stimulate sex steroid production by the senescent gonad. We found greater GH-mediated responses in LBM and fat in aged men than in women, consistent with prior reports in GH-deficient younger adults.

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The effects of HRT on body composition are controversial, although studies suggest that postmenopausal progestin can reduce tissue responsiveness to estrogens during HRT. Body composition changes observed could be of clinical ificance if they were associated with proportional improvements in strength, performance, and cardiac risk factors. Isotopic studies reveal that decreased LBM in nonelderly GH-deficient adults from reductions in cell mass and extracellular water, and that both components increase after GH replacement. The observed correlations of increases in strength and O 2 max with changes in LBM suggest that, in the current study, GH produced increases in functional muscle mass.

We observed a 6. Most 3043 but not all 44 studies reported no effect of GH on strength in aged individuals, consistent with our findings after GH alone. Although one epidemiologic study suggested that grip strength is greater in women taking HRT, 45 most prior cohort 46 or intervention 47 studies are consistent with ours in finding no increases in strength in HRT users.

Treatment of andropausal elderly men with higher doses of testosterone increased grip strength 48 and leg strength in some 49 but not other 18 studies. An increase of the magnitude observed would be expected after 6 to 8 weeks of regular resistance exercise 41 Wife seeking sex Harman, 42 and is potentially clinically ificant.

However, functional ificance of strength is better assessed by performance-based testing. ificant relationships of IGF-I with such measures have been Wife seeking sex Harman in elderly women, 50 but to date these outcomes have not been found to change in aged individuals after GH administration.

Our observation of a direct relationship of O 2 max with LBM is consistent with the interpretation that increments in O 2 max were partly due to increased muscle tissue and its consequent effect on oxygen consumption, rather than to enhanced cardiac output. Participants treated with GH exhibited soft tissue adverse effects similar to those reported in acromegaly, including edema, arthralgias, and carpal tunnel symptoms.

These effects were more common in men than in women, consistent with men's greater responsiveness to GH. We, like other authors, 51 noted spontaneous reductions over time in symptoms in some affected individuals. Older age may increase susceptibility to these adverse GH effects.

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Coadministration of sex steroid with GH did not increase incidence of soft tissue adverse effects. Studies of GH treatment have reported headaches in adult GH-deficient patients and benign intracranial hypertension with papilledema in children. Despite a ificant incidence of dependent edema, we detected no weight gain or increased blood pressure after GH administration.

Treatment with GH has been associated with increases in plasma renin activity 53 but not in plasma aldosterone 54 or blood pressure. Diabetes and glucose intolerance developed ificantly more often after GH treatment in men, as others have reported. We are unaware of analogous reports in aged adults. We found no effect of testosterone or HRT on glucose tolerance or diabetes, although testosterone replacement may improve insulin sensitivity in middle-aged men with low normal testosterone levels and obesity, 57 probably by decreasing central body fat.

Postmenopausal HRT exerts little effect on glucose tolerance. A recent study highlights concerns regarding neoplasia risk after long-term GH treatment in adults, 59 possibly related to the influence of elevated IGF-I levels. Menopausal HRT is Wife seeking sex Harman with small but ificant increases in breast cancer risk 16 ; estrogen use, unopposed by progestogens, increases rates of endometrial cancer.

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Aging and sex hormones in males