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NCT02031081
The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis slows digestion, it can lead to malnutrition and make controlling blood sugar even more challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and lifestyle modifications but treatments for more severe symptoms are limited. There are several drugs called pro-kinetics available in Canada though results vary among patients and these often cause significant side effects. Recently, a drug called Prucalopride was approved for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to cause few side effects. The investigators propose to test prucalopride as a treatment for gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The investigators will test the effects of this treatment by alternating 28 days of active treatment with prucalopride with 28 days of treatment with a non active placebo adding a two week break in between treatments. The order of the treatment will be randomized and neither the patients nor the investigators will know whether they are receiving the active treatment or the placebo until the study has been completely finished. The investigators will measure the effects using questionnaires that assess patient symptoms such as nausea and pain as well as quality of life during two gastric emptying tests and throughout the treatment periods. The effectiveness of the active treatment will be evaluated by comparing the extent of the change in symptoms before and after treatments and the difference in gastric emptying times as compared to the placebo treatment. The investigators will also monitor and track all possible side effects that patients experience during the study. Study Hypotheses In patients with gastroparesis: 1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by the change in cumulative meal-related symptoms. (primary endpoint). 2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo. (secondary endpoint). 3. A correlation exists between the effect of prucalopride on gastric emptying rate and symptom improvement.
NCT04126759
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
NCT04579341
Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration \> 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.
NCT03422263
The PUSH Study is conceived to investigate the early effects of SGLT-2-Inhibitors on the physical performance of patients with Type-II-Diabetes mellitus compared to patients under other therapy regimes. Patients shall be divided into 3 groups: I - Patients with type II diabetes mellitus under new treatment with an SGLT2-Inhibitor. II - Patients with type II diabetes mellitus without SGLT-2- Inhibitor medication. III - Patients without type II diabetes mellitus but with similar comorbidities to the previous groups.
NCT00952198
This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be enrolled in this study.
NCT04569396
The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.
NCT04573335
Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.
NCT01564719
This study seeks to test a two-year intervention designed for United Methodist clergy. The intervention consists of: the stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body. Participants were randomly assigned to one of three cohorts, all of which will eventually receive the intervention but which differ by intervention timing, thereby building in a randomized waitlist control group. The investigators hypothesize that intervention participants will achieve reductions in metabolic syndrome, depression, and stress, and achieve improvements in quality of life and spiritual well-being, compared to the waiting control group participants.
NCT02908152
The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.
NCT02456922
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years
NCT03729479
This study will compare the low-sodium/low-fat DASH (Dietary Approaches to Stop Hypertension) diet with a very low-carbohydrate diet, helping us to better understand how two different dietary approaches may help participants control their blood pressure, lose weight, and reduce their blood glucose.
NCT03972904
In the previous intervention studies of Type 2 Diabetes Mellitus patients, changes in blood glucose and insulin resistance profiles before and after intervention indicated that different intervention methods had different effects on outcomes. Therefore, this study intends to explore the effect of the Light-Fat Rice®combined with Active Peptide® on the level of insulin resistance in overweight/obese diabetic patients and its effect on the outcome through a 4-week, randomized, double-blind, controlled clinical trial, further elucidating its intervention mechanism theoretically. The study predicts that dynamic blood glucose(mean blood glucose) and glycosylated albumin will significantly different between the control group and the intervention group.And insulin resistance levels, blood lipids and other indicators wil be improved, and the test group was superior to the control group.All of these will contribute to more scientific and effective Type 2 Diabetes Mellitus's management.
NCT03648424
This cohort study was initiated to predict the findings of CAROLINA trial in a real world setting using electronic claims data from insurance databases with results anticipated prior to the completion of CAROLINA.
NCT00837408
Objectives: * To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among Han Chinese. * To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort. * To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples. * To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in Han Chinese. Eligibility: * Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects are nondiabetics, age and ethnically matched to patients. Design: * The study design for both patients and controls consists of the following steps: * Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff. * Assign study ID (barcode) * Administer questionnaires * Obtain spot urine sample * Measure blood pressure * Obtain anthropometric measurements including body composition * Perform finger prick for blood glucose level * Obtain venous blood samples * Perform eye examination * On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result * DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in China. * GWAS will be conducted using publicly available software packages.
NCT04562454
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). GI is currently widely used to provide guidance on food choices for people with diabetes. However, there are great differences in blood glucose response among different individuals after eating the same food, which is related to a variety of factors,including individual gastrointestinal digestion and absorption rate,islet function,insulin resistance and region. A large number of foreign studies suggest that race affects the determination of GI, but different regions of our country have different dietary culture and different ability to digest and absorb different foods. Therefore, the traditional GI reference value does not necessarily fully reflect the blood glucose response of diabetic patients after eating a food. In this study, continuous blood glucose monitoring was carried out through CGM to monitor the overall fluctuation level of blood glucose, the time to peak and the range of blood glucose fluctuation after eating specific foods, and to obtain individual GI, after eating different diets to guide the future diet.
NCT03829982
This study evaluates the effect of bright light on postprandial blood glucose metabolism in obese subjects with impaired fasting glucose and/or impaired glucose tolerance.
NCT03017287
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.
NCT02164279
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. However, it is a late (because it permits to detect a renal disease already present), non-specific and low sensitive biomarker. Therefore the main objective of this study is to identify early urinary biomarkers predictive of DN in children with type I diabetes, before the appearance of a microalbuminuria.
NCT04555421
To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes..
NCT03489967
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.