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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT04219787 Active, not recruiting - Hypertension Clinical Trials

Different Limb Lengths in Gastric Bypass Surgery

SLIM
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.

NCT ID: NCT04217161 Active, not recruiting - Diabetes Clinical Trials

Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

DEXCOM-HD
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (CGM) measured by a Dexcom G6 device vs. 2) "gold-standard" blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (POC) blood glucose meter. The study will assess Dexcom G6 accuracy by comparing glucose levels on the CGM device vs. blood glucose measurements in the study population.

NCT ID: NCT04196348 Active, not recruiting - Obesity Clinical Trials

Surgical Innovation for Diabetes Treatment

SURIDIAB-1
Start date: March 28, 2019
Phase: N/A
Study type: Interventional

This study will determine how two variants of gastric bypass induce changes in dynamic endocrine response in the fasting and post-prandial state, both before and at different time points after the surgical interventions. This study will monitor the endocrine dynamics after different anatomical modifications produced by Roux-en-Y gastric bypass procedures in diabetic participants and normoglycemic participants, to gain insights into the mechanisms beyond the metabolic improvement after the two surgical variants through participants re-evaluation at different time points.

NCT ID: NCT04195477 Active, not recruiting - Diabetes Prevention Clinical Trials

vDPP Facilitated With Community Care Coordination

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes.

NCT ID: NCT04161937 Active, not recruiting - Diabetes Clinical Trials

Work-Site Intervention Study to Prevent Diabetes in Nepal

WSS
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The burden of non-communicable disease is on the rise in low- and middle- income countries.Cardiovascular disease is the leading cause of morbidity, mortality, and disability in South Asian regions. Diabetes mellitus is among the top five risk factors for cardiovascular deaths in the world. Despite the evidence supporting the use of lifestyle interventions to prevent diabetes and improve glucose tolerance, their translation in real world has been challenging. Work-site-based health programs have shown positive impacts on employee health, and have shown significant improvements in blood glucose levels and HbA1C. The research will be conducted in 1) Hulas wire Industry and 2) Pragati Textile Industry Private limited. Investigator will conduct before-and-after intervention among pre-diabetic employees.In addition screening will be done to identify the eligible participants.Those who are pregnant,under diabetic and hypertensive medication will be excluded from the study. All of the interested adult employees (≥18 years) will be invited for the first screening. All individuals with HbA1C from 5.7% to 6.4 % will be invited to participate in the study. At baseline, investigators will administer a standardized questionnaire to record the characteristics of the participants.Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile. Investigators will have a wait period before implementing any intervention.After completion of control period,half of the participants will be randomized to receive behavioral interventions. Behavior intervention will comprise of combination of intensive education session, group counseling, goal setting and monitoring.Trained nurses will deliver the sessions once every week for two months and then once every month.All the participants will receive canteen intervention after behavioral intervention which will comprise of promotion of healthy foods in the canteen of the study site i.e Improve physical facility ,increase access to healthy food, Information, Education and communication, changes in food price and training of canteen staffs Investigators will conduct follow up at 6 months, 12 months, and 18 months and if funds are available at 24 months. During each follow up, the proportion of unhealthy diet consumption data will be abstracted. In addition, blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile .This period will serve as control group.

NCT ID: NCT04150315 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Arterial Composition and Cardiovascular Outcome in DIabeteS

ACCODIS
Start date: June 1, 2018
Phase:
Study type: Observational

1. People living with type 2 diabetes are told that they have a significantly higher risk of developing a disease related to the heart or blood vessels. These diseases can play a major role for the overall health of the patient and can even cause death due to a blood clot in the heart, brain or other parts of the body. Understandibly, this information can cause a great deal of stress and anxiety for the patient. As of today a doctor can not determine which patient has a higher risk of disease in the Heart and blood vessels. Therefore, we see a great need for further exploration of the mechanisms that could help identify diabetic patients with a particularly high risk of developing these diseases. In this PhD project we aim at identifying diabetic patients with a specific pattern in the amount of proteins in the blood, tissue and genetic material who are at high risk of death or disease related to the heart and blood vessels. We explore this problem from two angles. In the first part of the PhD study, we identify and measure proteins, which are related to high risk of disease in the heart and blood vessels. These proteins come from the blood vessels (a specific part called the basement membrane) and are believed to be present in a higher concentration, when people have diabetes. At the same time, we measure the same proteins in a blood sample from the patients, and we also examine their genetic properties with a focus on specific genetic areas. All the tissue and blood samples have already been collected from patients, who have undergone a by-pass operation in the Heart at Odense University Hospital since 2008. All of the material is stored in a biobank (Odense Artery Biobank). We also collect data from Statictics Denmark about each individual. These data are used to categorize people into risk categories. We then hope to see a pattern in the measurements from the laboratory that match the risk profile of the patient. In the second part of the study we use a different approach. Data from a large study done on the population of Malmö, Sweden, can be used to examine the Development of blood vessels in diabetic patients. In this study healthy people from Malmö have undergone a number of examinations in the early 1990'ies and again 15 years later. One of the tests was an ultrasound of the large blood vessel on the neck, the carotid artery. With this ultrasound we are able to measure the thickness of the wall of the blood vessel and the diameter in which the blood can pass through. We think that there is a connection between diabetes and the diameter of the blood vessel and that, over time, diabetes can cause the blood vessel to become narrower. This idea links the two studies because the same proteins that can be found in the first study are important in determining the risk of having a narrow blood Vessel when the patient has diabetes. 2. This project can contribute with a deeper knowledge about the linking mechanisms between diabetes and disease in the heart and blood vessels: which proteins are present in higher concentration? How does this relate to a higher risk? How do diabetic blood vessels change over time? We will aim at answering these questions. With regards to clinical practice, we see several perspectives: - deeper knowledge and understanding of the mechanisms behind the diasease in the heart and blood vessels that follows diabetes - development of a new blood test. Over time, the proteins measured in this study could be developed to a new blood test that gives information about a patients risk of developing a diasease in the heart or blood vessels - better treatment for patients with diabetes because aptient with high risk can be treated more intensely In order to achieve the goals of this project there are several overall tasks: - select patients form the biobank, that are suitable for the project (the correct type of tissue and blood sample available) - do work in the laboratory. This includes cutting and preparing tissue, analyzing the tissue and blood samples, implementing new methods for analysis etc. - collect clinical data form Statistics Denmark. This process can be quite detailed and time consuming. - obtain data from 'The Diet and Cancer Study' in Sweden, Malmö - analyze data from study 1 - analyze data from study 2 - write articles - collect all parts of the projects in the final thesis

NCT ID: NCT04108455 Active, not recruiting - Clinical trials for Gestational Diabetes

Biomarkers During Pregnancy

Start date: March 15, 2019
Phase:
Study type: Observational

This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women.

NCT ID: NCT04094194 Active, not recruiting - Obesity Clinical Trials

Meta-analysis of the Nordic Dietary Pattern on Cardiometabolic Risk and Cardiovascular Outcomes

Start date: December 1, 2017
Phase:
Study type: Observational

The Nordic Diet is a dietary pattern rich in traditional Nordic foods, including berries, grains, and fatty fish common in northern Europe. Studies have shown a protective effect of the Nordic Diet on cardiometabolic risk factors, however only select clinical practice guidelines for the management of diabetes (i.e. Diabetes Canada) recommend this dietary pattern. To support the update of the EASD clinical practice guidelines for nutrition therapy, the investigators propose to conduct a systematic review and meta-analysis of prospective cohort studies and clinical trials to investigate the association between the Nordic Diet, cardiometabolic outcomes and cardiovascular disease incidence and mortality. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

NCT ID: NCT04078308 Active, not recruiting - Diabetes Mellitus Clinical Trials

Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients

MSCTXT1DM
Start date: July 6, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving regeneration. Study design and method: In a Triple blinded randomized placebo-controlled phase I/II clinical trial, 20 patients with newly diagnosed type-1 diabetes who would be visited in Children's Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group and the placebo group. Participants: Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. Interventions: Intravascular transplantation of autologous mesenchymal stem cells in the case group; placebo injection in the control group. Outcome variables: safety and efficacy.

NCT ID: NCT04067440 Active, not recruiting - Obesity Clinical Trials

Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool

METABIOM
Start date: October 1, 2019
Phase:
Study type: Observational

Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.