View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:This project examines whether individuals' amount of activity energy expenditure (AEE) is related to adiposity and adiposity/diabetes-related hormones in a diverse sample of 2500, and to test the ecological hypothesis that a decline in levels of AEE is an important cause of the increases in obesity that are currently taking place in many societies. One goal is to use doubly labeled water and/or accelerometers to objectively measure activity energy expenditure in community samples from five adult populations across the spectrum of obesity risk. From each site, (i.e., Ghana, South Africa, Seychelles, Jamaica, and the US), 500 black adults will be recruited. Among all participants, AEE will be measured using accelerometers and in a subset of 75 per site, AEE will also be measured by doubly labeled water. The doubly labeled water sample will be used to confirm site-specific concordance with the accelerometer measurements and to estimate population mean levels of AEE. Additionally, body composition, dietary intake, fasting glucose, insulin, adiponectin, leptin and ghrelin will be measured. The relationships between calories expended in activity and body composition, dietary intake, glucose, hormones and adipocytokines, both within and between each population using doubly labeled water and accelerometers will be examined. In this longitudinal study, weight will be measured at 12 and 24-months, and AEE by accelerometer will be assessed at enrollment and again at 2-years of follow-up; associations between change in AEE and change in weight will be estimated. The central purpose of this project is to test whether AEE or change in AEE can be identified as a contributory mechanism to population-wide weight gain and, if so, to quantify its importance. In addition, we seek to understand the interrelationships between the adipocytokines and the hormones ghrelin and insulin as well as AEE in the regulation of body weight across the continuum of body mass indices (BMI) represented by these five populations.
Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients will be recruited by research publication in diabetes mellitus forums. Baseline visit: informed consent signing. Medical history data, vital signs, physical exam and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl. Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment, neurocognitive testing, and sleep quality assessment. Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl and at glucose < 180 mg/dl, respectively. Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2. Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed with glucose level > 70 mg/dl and below 180 mg/dl. On day 2, with no regular insulin dose before lunch and the same cognitive test will be performed with glucose level > 240 mg/dl During the 30 hours the participants will be connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and research team will be blinded to the EEG and CGMS readings while recorded. Participants will be able to convey their daily activities in their room. They will have their regular diet and regular daily activities. Participants will measure at least 4 blood glucose measurements by prick tests, insulin management by multiple daily injections or pump therapy and meals. Healthy participants will measure twice daily as required for CGMS calibration. The participants will stay connected to the CGMS for additional 4 days at their home setting for complete sleep quality assessment by sleep diary and actigraph. The first night in hospital is to assess the association between actigraph and EEG and CGMS variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph readings. Control group (healthy) will perform only one session of neurocognitive studies on day 1, after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS and actigraph
There are numerous possible reasons why it could be speculated that HbA1c variability may affect complication risk. Of interest are the concepts that both laboratory and clinic evidence suggests that periods of sustained hyperglycemia are 'remembered' (metabolic memory), this in turn is recognized to place patients at greater long-term risk of complications. As such it can be speculated that the detrimental effect of variability in HbA1c may be mediated via the same mechanism as 'metabolic memory' phenomenon. Aims: To determine whether treatment to one of 2 threshold levels will result in one group of type 2 diabetes patients having the same mean HbA1c but with differing HbA1c variability to that of another and related to markers of oxidative stress, inflammation and microvascular complications. To determine whether a difference in HbA1c variability between the 2 groups will reflect in changes in small nerve fibers assessed with the sensitive method of corneal confocal microscopy and cardiac autonomic function testing. To assess the reproducibility of HbA1c measurement from a whole blood samples initially analyzed and then stored at -80C until the end of the study (2-3 years), as well as storing an aliquot of haemolysate, for reanalysis at the end of the study. In one arm the investigators will intensify treatment in those with FPG>140mg/dl until their FPG is <90mg/dl, using whatever treatment is clinically appropriate for them, and only intensify it further if their FPG rises to >140mg/dl again. In the other group the investigators will intensify if their FPG is >115 mg/dl until it is <=115 mg/dl and intensify further if >115 mg/dl again. A total of 20 visits within a time frame of 2 and half years will be performed. Visits procedures will include routine biochemistry, eGFR, lipids, fasting glucose, insulin and full blood count, HbA1c, SHBG, hsCRP. EPIC and G-PAQ questionnaires will be collected. Autonomic function testing using deep breathing heart rate variability, and a sensitive measure of small fiber neuropathy using corneal confocal microscopy and a 24 hour urine collection for urinary isoprostanes to measure oxidative stress will be performed, at baseline, 12 and 24 months.
The purpose of the study is to use a novel treatment approach, the artificial pancreas, after diagnosis of type 1 diabetes (T1D) to improve glucose control with the anticipated improvements of residual C-peptide secretion. This is an open-label, multicentre, single-period, randomised, parallel group design study. It is expected that a total of up to 190 subjects (aiming for 96 randomised subjects) will be recruited within ten working days of diagnosis of type 1 diabetes through paediatric diabetes centres in the UK. Half of the participants aged 10 to 16.9 years will be treated by conventional insulin injections and the other half by the artificial pancreas (closed loop insulin delivery system). Each treatment will last 24 months. All participants completing the 24 month study period will be invited to continue in an optional extension phase with the treatment allocated at randomisation for a further 24 months. Subjects in the intervention group will receive additional training on components of the artificial pancreas, i.e. insulin pump and continuous glucose monitoring (CGM), prior to starting closed loop insulin delivery. Subjects in the control intervention group will continue with standard therapy, i.e. multiple daily injection therapy. The study includes up to 14 visits and 1 telephone/email contact for subjects completing the study. After run-in and randomisation, visits will be conducted every 3 months in both arms. Beta-cell function will be assessed by serial measurement of C-peptide in response to a standardised mixed meal tolerance test (MMTT). MMTTs will be conducted at baseline, 6-,12- and 24 months post diagnosis. The primary outcome is the between group difference in the area under the stimulated C-peptide curve (AUC) of the MMTT at 12 month post diagnosis. Secondary outcomes include between group differences in stimulated C-peptide AUC over 24 months, differences in glycaemic control as assessed by HbA1c, time spent in glucose target range, glucose variability, hypo- and hyperglycaemia as recorded by periodically applied CGM, as well as insulin requirements and change in bodyweight. Additionally, cognitive, emotional and behavioural characteristics of participating subjects and parents will be assessed, and a cost utility analysis on the benefits of closed loop insulin delivery will be performed. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) and number, nature and severity of other adverse events.
Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients. Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team. The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decision affected by the research is at the practice level: whether and how to use behavioral health services. The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects in 40 practices with co-located behavioral health services. Practices randomized to the active intervention will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH. The investigators plan to study adults who have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.
The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.
The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the non-diabetic group while the diabetic volunteers will be randomised to a diabetic control intervention group or a diabetic fish intervention group. Baseline data will be collected from all three groups but only diabetic control intervention group and diabetic fish intervention group will go through the 16-week study. This will allow the investigators to compare the metabolic health across South Asian population in people with and without diabetes. The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control intervention group will continue with their habitual diet, while subjects in the diabetic fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA intervention study among South Asian people in the United Kingdom was able to reverse lipid abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171 mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase compliance. Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be recruited only to obtain baseline data in order to compare their metabolic profile with that of the diabetic volunteers. This will allow us to investigate the link between omega 3 status and glycaemic control in a South Asian population. Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key nutrients such as vitamin D, selenium and iodine.
The overall objective of the proposed cluster randomized trial is to test whether implementation of protocol-based integrated care will improve CVD risk factors (glycated hemoglobin [HbA1C], systolic blood pressure [SBP], and LDL-cholesterol) over 18 months and reduce major CVD events (non-fatal stroke, non-fatal myocardial infarction, hospitalized heart failure, and CVD mortality) over 3 years among patients with type 2 diabetes and additional CVD risk factors or clinical CVD compared to usual team-based care in community clinics in Xiamen, China.
The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management support system for chronically ill patients and informal caregivers. 60 end-users will be instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others, clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be evaluated to determine its potential future scalability.
The study is a phase 2, monocentric, open-label study. The investigators will recruit 12 patients with T1D to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm A, n=6) or directly into the omentum (arm B, n=6). Patients will be selected from those eligible for islet Tx based on local practice and guidelines. Immunosuppression will consist of five doses IV infusion of rabbit Anti-thymocyte Globulin (ATG, Thymoglobulin®), starting two days prior to the islet transplant. Maintenance mycophenolate mofetil (MMF) therapy (1-2 g/day as BID dosing) will be started on Day -1 pre-transplant. Tacrolimus will be administered orally twice daily on Day 1 post-transplant to maintain a trough level of 10-12 ng/mL for 3 months, then 6-10 ng/mL thereafter. Etanercept will be given IV before the islet transplant (50 mg), and then at 25 mg (subcutaneously) on POD +3, +7 and +10.