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Endocrine System Diseases clinical trials

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NCT ID: NCT03018886 Completed - Clinical trials for Growth Hormone Deficiency

Diagnosing Adult Growth Hormone Deficiency

Start date: May 2001
Phase: N/A
Study type: Interventional

The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test

NCT ID: NCT02976350 Completed - Heart Failure Clinical Trials

Hormone Deficiency in Heart Failure With Preserved Ejection Fraction

MHDS in HFpEF
Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

NCT ID: NCT02946606 Completed - Clinical trials for Adult Growth Hormone Deficiency

A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.

NCT ID: NCT02925299 Completed - Diabetes Mellitus Clinical Trials

Day and Night Closed-loop in Young People With Type 1 Diabetes

DAN05
Start date: May 12, 2017
Phase: N/A
Study type: Interventional

The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group). It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy. Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).

NCT ID: NCT02823249 Completed - Clinical trials for Endocrine System Diseases

Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions

Start date: May 2014
Phase: N/A
Study type: Interventional

With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.

NCT ID: NCT02782208 Completed - Insulin Resistance Clinical Trials

Lipolytic Effects of GH in Hypopituitary Patients in Vivo

Start date: February 10, 2016
Phase: N/A
Study type: Interventional

Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These protein anabolic effects require sufficient nutritional supply. During fasting and caloric restriction GH predominantly promotes fat metabolism. GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose uptake in skeletal muscle has been most extensively studied. Substrate competition between elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the fat metabolizing effects of GH. The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism. In order to investigate this, eight adult hypopituitary patients with documented GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively, and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed. Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.

NCT ID: NCT02781727 Completed - Clinical trials for Endocrine System Diseases

A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Start date: December 13, 2016
Phase: Phase 3
Study type: Interventional

A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.

NCT ID: NCT02718885 Completed - Clinical trials for Nutritional and Metabolic Diseases

Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients

Start date: May 2016
Phase: Early Phase 1
Study type: Interventional

The overall objective of the study is to examine the changes within the gut microbiome after the supplementation of inulin and its effect on markers of mineral metabolism and bone turnover.

NCT ID: NCT02693522 Completed - Clinical trials for Growth Hormone Deficiency

Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

Start date: October 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

NCT ID: NCT02649907 Completed - Weight Loss Clinical Trials

Effects of Weight Loss on Nutritional Mediated Hormone Secretion

RepDiet
Start date: September 12, 2015
Phase: N/A
Study type: Interventional

Investigative trial with aim of 1. the description of the hormonal and metabolic response to meals containing different compositions of macronutrients 2. the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and 3. effects of a weight loss on the hormonal response to these test meals containing different compositions of macronutrients Primary endpoint: Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin response to a nutritive stimulation characterized by different nutritional composition Secondary endpoints: - differences of substrate utilization depending on the nutritive composition - effects of different hepatic and muscular insulin sensitivity as well as impact of visceral fat mass on the hormonal and metabolic response - effect of weight loss on the hormonal and metabolic response to different test meals Study procedure: After primary characterization 50 probands (male and female) will receive 3 different test meals within a randomised (meal order) controlled trial. The three different test meals differ in nutritional composition. During consumption of the test meal a characterization of the endogenous hormonal response and appetite behaviour is performed. A nutritional counselling is performed according to the guidelines of the German Nutrition Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal administration. After analysis of the hormonal response to these 3 different testmeals follows a weight reduction period over 3 months. Afterwards reevaluation of the probands (again administration of 3 different test meals over a period of 3 weeks) will be performed. Principal aim of the study: Gain of information leading to the understanding of the hormonal regulation of food intake. The individual variability shall be determined with the aim of an identification of patient groups which show various intensities of the responses to different macronutrients.