A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
Diabetes MellitusType 23 moreThe purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin. The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status. Additional measures include fasting glucose, and lipid levels, and body weight. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.
Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth...
AcromegalyGrowth Hormone Deficiency1 moreThe purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in the brain, called the pituitary, produces too much growth hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by treatment received. We will study the effects of growth hormone replacement on the health of the heart and blood vessels of GH deficient persons by looking to see if this therapy: has effects on cardiovascular risk markers (special blood tests which indicate how healthy your heart and arteries are) affects the stiffness of the arteries affects your heart rate and the capacity of your heart to respond to changes in body position has different effects depending on whether you are taking estrogen / testosterone. We will assess these measures of health on one occasion in persons with cured acromegaly and normal GH levels and in persons with cured acromegaly who have GH deficiency and a contraindication to receiving GH. GH deficient individuals with no contraindication to receiving GH, will participate in the study for 12 months. Individuals with normal GH levels, or who are GH deficient and have a contraindication to receiving GH, will be asked to return for one more visit (without any interventions).
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Growth Hormone DisorderAdult Growth Hormone DeficiencyThis trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.
Effect of Growth Hormone in Children With Growth Hormone Deficiency
Growth Hormone DisorderGrowth Hormone Deficiency in Children2 moreThis trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone DeficiencySepto-Optic Dysplasia1 moreHypotheses: The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: Determine the prevalence and types of endocrinopathies in children diagnosed with ONH. Correlate endocrine outcome with radiographic, ocular, and developmental findings in children with ONH. Examine the effect of GH treatment on growth and obesity in children with ONH, GH-deficiency, and either subnormal or normal growth compared to children with ONH that are not GH-deficient. Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies.
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone...
OsteoporosisGrowth Hormone DeficiencyOBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo. II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH. III. Compare the quality of life of these patients treated with these 2 regimens. IV. Determine the side effects of GH in these patients.
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Diabetes MellitusType 111 moreThe objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
Bariatric Surgery, Hormones, and Quality of Life
ObesityHormone Disturbance2 moreThe purpose of this study is to characterize the hormonal status in fertile women undergoing laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation between health-related quality of life and proposed hormone changes post-operatively.
Preservation of Ovarian Tissue and Chemo-Radiotherapy
Endocrine Disorders of Female Reproductive SystemSecondary Infertility1 moreThe purpose of this study is to assess the results of ovarian tissue freezing, such as resumption or initiation of menses (menstruation: the discharge of blood and tissue from the uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who are about to undergo chemotherapy or radiation therapy for cancer or these other medical conditions may stop having menses and may not be able to produce a biological child. Girls who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing and preserving ovarian tissue will help prevent these outcomes. In fact, when you are considered cured of your disease, you will have another surgical procedure where your own ovarian tissue will be transplanted back to you. This surgery will increase the possibility of resuming/initiating menses and the chance to have a pregnancy.
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency...
Adult Growth Hormone DeficiencyThe purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.