View clinical trials related to Gastroparesis.
Filter by:A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis
Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur in the absence of any structural abnormality of the stomach, rather abnormal gastric function underlies the condition. Up to one in five patients with type I diabetes experience symptoms consistent with this diagnosis. The effects on diabetic control, physical health and emotional quality of life are severe. Patients do not respond reliably to general supportive management or conventional medications. Surgical options have disappointing results. The need for more effective treatment is acknowledged universally. Feeding into the small bowel beyond the stomach (jejunal feeding) is established management in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake. The benefits have been assumed secondary to improved nutrition and diabetic control; however this assertion has never been studied. Recently we observed that patients with severe gastroenteropathy recovered promptly and could eat normally during and for a few hours after jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological' effects in patients with gastroenteropathy. One attractive explanation for these observations is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the normal fed state by bypassing the dysfunctional stomach. This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without symptoms will also be investigated. Studies will assess: 1. Effects on GI symptoms and function to gastric distension in fasted and fed states 2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal 3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to assess complex gastric response to feeding. In addition the effects of feeding on symptoms and gastric function will be related to alterations in GI hormones and autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response of the GI tract to feeding fails in patients with diabetic gastroenteropathy. The primary aim of this project is to assess the effectiveness of jejunal feeding in the management of diabetic gastroenteropathy. However, by defining the processes that 'switch' gastric function between the fasted and the fed states and control gastric emptying, we hope also to identify candidate targets for more effective pharmacologic treatment of this severe disease. - Trial with medical device
The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment. Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for each patient. After a run-in period of 4 months during which a prospective assessment of healthcare resources utilization and of the severity of the symptoms will be obtained, patients will be implanted. The follow-up period after implantation of the device will last 24 months in every patients and will be divided in two parts: a) After the first postoperative month during which the device will remained on the "OFF" position, the first phase of the study will be a randomized double-blind cross-over study with 2 periods of 4 months during which the device will be activated or not. After the 9th month of follow up, the trial will be an open trial and the device will be activated in all patients. During the whole trial, patients will record all types of healthcare resources utilizations (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of the treatment will be assessed by standard questionnaires at the following visits scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but we have planned to analyze the clinical results of the treatment in taking into account a delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric electrical stimulation on gastric emptying.
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.Treatment with acupuncture has been described as effective in improvement of symptoms in patients with gastroparesis in a number of patient series. However, this treatment approach has not been tested by means of a controlled randomized clinical study, and neither has the connection between improvement of symptoms and the anatomical-physiological effect of the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice daily) as compared to acupuncture treatment on the following subjective and objective parameters of 30 patients with diabetic gastroparesis and impaired glucose control: 1. To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire. 2. To determine the effect of treatment with motilium or acupuncture on gastric emptying rate. 3. To determine the effect of treatment with motilium or acupuncture on glycemic control. 4. To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).
The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.
To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.
The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.