Sintomas gastrointestinais. Motilidade gastrointestinal. Foram investigados pacientes com Diabetes Mellitus, sendo 26 do tipo 1 e do tipo 2, e 50 pessoas aparentemente sadias, que integraram o grupo controle. METHODS: The frequencies of 13 digestive symptoms were determined in type 1 and type 2 diabetics and in 50 apparently healthy controls, utilizing a structured, standardized questionnaire. The frequencies of symptoms observed in Brazil were similar to those reported in studies from the North Hemisphere, a finding that does not support the hypothesis that external factors may influence the prevalence of gastrointestinal symptoms in diabetics. Diabetes mellitus.
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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned. As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to.
Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. Title of the trial for lay people, in easily understood, i.
Diabetic Gastroparesis Study 1. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy.
Comparar la seguridad de la relamorelina frente al placebo en participantes con gastroparesia diabetic. Male and female participants aged 18 years or older at screening Visit 1 2. DG defined as at least a 3-month history prior to screening Visit 1 of symptoms on an ongoing basis that are suggestive of GP eg, nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety 5.
Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period A female participant is eligible to participate if she is not pregnant has a negative urine pregnancy result prior to randomization , not breastfeeding, and at least one of the following conditions applies: a.
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment 6. Documentation of absence of an obstructing lesion on upper endoscopy or other equivalent diagnostic test, performed at some time before screening Visit 1 but after the appearance of symptoms that led to the diagnosis of DG 7.
At least 2 vomiting episodes during the 2 weeks prior to screening Visit 1 , as ascertained by participant history 8. Able to provide written informed consent IC prior to any study procedures and willing and able to comply with study procedures Additional inclusion criteria for randomization after the 2-week, placebo Run-in Period: Compliance with the entry of data into the hand-held electronic device on at least 10 of 14 days during the placebo Run-in Period Compliance with administration of SC twice daily injections, as evidenced by entries made by the participant using the electronic, hand-held device on at least 10 of 14 days during the placebo Run-in Period At least one vomiting episode at any time during the placebo Run-in Period, as recorded in the DGSSD, using the electronic hand-held device History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of screening Visit 1 4.
History of intestinal malabsorption including celiac disease even if well-controlled on a gluten-free diet or pancreatic exocrine insufficiency; also, history of non-celiac gluten sensitivity 5. History of belching disorders, other nausea and vomiting disorders eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome , or rumination syndrome 6.
History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention 7. Gastric or duodenal ulcer within 3 months of Screening Visit 1 8.
History of malignancy in the 3 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics eg, erythromycin, clarithromycin, azithromycin , or other drugs considered to be GI pro-motility agents for at least 10 days prior to the start of the Run-in Period Visit 2 Positive results on the urine drug screen at Screening Visit 1.
The significance of a positive screen result for drugs prescribed for the participant e. Currently taking opioids, or expecting to use opioids during the course of the clinical study Treatment with glucagon-like peptide-1 GLP-1 agonist for at least 6 weeks prior to the start of the Run-in Period Visit 2 History of pyloric injection of botulinum toxin within 6 months of screening History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure a history of diagnostic endoscopy is not exclusionary Randomization in any previous study in which relamorelin was a treatment Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal Females who are pregnant, nursing, or planning a pregnancy during the study Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of Allergan, Inc.
Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus. Mujeres embarazadas, en periodo de lactancia o que tengan previsto quedarse embarazadas durante el estudio Dispepsia funcional diagnosticada antes que la diabetes mellitus.
Acontecimientos adversos adverse event, AE , valores de laboratorio, constantes vitales, electrocardiogramas ECG , HbA1c y anticuerpos antirrelamorelina.
The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. The end of the study is defined as the date of the last visit of the last participant in the study.
Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.
Participants who successfully complete this study are eligible to enter a placebo-controlled, long-term safety and efficacy study LTSES RLM-MD during which they will receive study treatment for an additional 46 weeks.
Mecanismos e fatores associados aos sintomas gastrointestinais em pacientes com diabetes melito. Foram selecionados os artigos mais atuais e representativos do tema. The most relevant and up-to-date articles on the topic were selected. The complications caused by this disease in the digestive system, such as gastrointestinal symptoms nausea, vomiting, abdominal pain, heartburn, dysphagia, constipation, diarrhea, and fecal incontinence are well known. The pathogenesis of changes in the gastrointestinal functions in patients with diabetes mellitus is still being investigated at the same time as the role of the enteric nervous system and its neurotransmitters has gained significance. As a consequence of the complications in the digestive system, which damage the enteric nervous system, patients with diabetes mellitus may have specific gastrointestinal motility disorders, some of which may be of great relevance, such as diabetic gastroparesis, constipation, and diarrhea. Gastrointestinal dysfunction increases the morbidity of diabetes mellitus and worsens the quality of life of diabetic individuals.
Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field.