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NCT00103857
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
NCT02726217
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c\>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.
NCT00758069
A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
NCT02532101
Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.
NCT01961024
In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2 diabetic and healthy subjects matched for BMI in order to elucidate the potential pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes that might be involved in regulating skeletal muscle and adipose tissue FA storage.
NCT02115711
The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.
NCT01777282
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
NCT01581099
Introduction- Primary prevention is the main strategy to control the global burden of cardiovascular disease. In clinical practice, food restriction represents a valuable preventive resource. However, low adhesion rates and diet abandonment are considered important obstacles in treatment. Considering the discovery of new markers and mechanisms that relate food restriction and to all other cardiovascular risk factors, it is possible and necessary to seek for efficient alternatives to increase adherence and effectiveness of the preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food restriction. The bariatric surgery have gained importance not only for its potential application in obesity treatment but also in the control of cardiovascular risk factors refractory to medical treatment. Among bariatric operations, there is a group called digestive adaptations III that has specific characteristics.This surgical intervention modifies intestinal tract by reducing gastric volume and performing an anastomosis between ileum and stomach, creating a bipartition in the gut. This structural modification promotes satiety and increased insulin sensitivity more intensely than other surgical strategies. The effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers related to the development of atherosclerosis are not yet established. Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and laboratory parameters and cardiovascular risk factors. Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal obesity will be included in the study. Of this group, half will be randomly selected to perform the Digestive Adaptations III surgery. All participants will undergo clinical and biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four months after surgery. On these occasions besides the lipid profile and glucose, we will determine incretin hormones, adipokines and assess the amount of epicardial fat.
NCT02251301
The purpose of this study is to investigate whether combining interval training with skim milk supplementation will result in improved glucose control and markers of cardiovascular health in people with type 2 diabetes. Participants will complete supervised interval training three times a week over a 12 week training period while consuming skim-milk, whey/casein protein drink, or a placebo beverage that does not contain any calories or vitamins/minerals immediately and 1 hour after each training session. After twelve weeks participants will repeat baseline tests to examine any effects of the intervention on their glucose control, fitness, blood vessel function, body composition, and blood markers of inflammation.
NCT02148991
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction and increased thickness of the vessels. Co-existing diseases, such as diabetes mellitus, renal dysfunction, sleep apnea, etc. further aggravate the prognosis of these patients. In addition the rate of patients aged \> 65 years suffering from un-diagnosed or diagnosed arterial hypertension was 78% for women and 64% for male patients. This population consists from elderly or very elderly patients (over 65 and 80 years respectively) who exhibit more comorbidities and probably less compliance with antihypertensive therapy. Finally, at every age the disease and its effects can affect the quality of life of patients. The main purpose of this study is to investigate the efficacy of antihypertensive therapy (irbesartan alone or in combination with amplodipine and carvedilol) on the cardiovascular system (diastolic left ventricular function, the function of the endothelium (FMD) and the thickness of the common carotid artery). The secondary objective of the study is to monitor the quality of life (Quality of Life - QoL) of patients. Additionally the investigators will seek the correlation of results with co-morbidities, compliance, and patient age.
NCT01232491
This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).
NCT01754467
Sedentary behavior is associated with an increased risk of mortality and many health conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥ 20 minutes) with either light or moderate intensity activity for 2 minutes reduces postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health consequences of sedentary behavior. The purpose of this study is to develop a smartphone application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least 2 minutes. Following the development, testing, and refining of the application, a sample of 10 sedentary adults with type 2 diabetes will be recruited to participate in a one month trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the first study to design and examine the acceptability of a smartphone application that will target interrupting sedentary behavior with NEAT using objectively measured sedentary time in a diabetic population.
NCT02034266
Nerves are made of different fats including omega-3s and omega-6s; however, dietary intakes of omega-6s are very high and omega-3 intakes are very low. We hypothesize that omega-3 supplementation will stop diabetes related changes in cornea nerve structure in patients with type 1 diabetes to stop the development of nerve injury associated with future risk of neuropathy, and reflect changes in the degree of nerve injury over time. As such, we anticipate that patients in the study will maintain Corneal Nerve Fiber Length (CNFL), the primary outcome measure.
NCT01950650
This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.
NCT03130894
Background: The association of trimethylamine-N-oxide (TMAO), a microbiota dependent metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent. Objective: The investigators planned to investigate the association between plasma TMAO and newly diagnosed type 2 diabetes as well as whether the association could be modified by the TMAO-generating enzyme flavin monooxygenase 3 (FMO3) polymorphisms. Design: This is an age- and sex-matched case-control study of 2694 participants: 1346 newly diagnosed cases of type 2 diabetes and 1348 controls. The patients of newly diagnosed type 2 diabetes were consecutively recruited from those attending for the first time the outpatient clinics of Department of Endocrinology, Tongji Medical College Hospital, Wuhan, China, from 2012 January to December 2014. Concomitantly, the investigators recruited healthy individuals who were frequency-matched by age (±5 years) and sex to patients from an unselected population undergoing a routine health check-up in the same hospital. The inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (BMI) \< 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological treatment for hyperlipidaemia or hypertension. Patients with clinically significant neurological, endocrinological or other systemic diseases, as well as acute illness or chronic inflammatory or infective diseases, were excluded from the study. All the participants enrolled were of Chinese Han ethnicity. All the participants gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation. The study was approved by the ethics committee of the Tongji Medical College. Concentrations of plasma TMAO were measured, and FMO3 E158K polymorphism (rs2266782) were genotyped.
NCT01292590
The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.
NCT01869790
The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat. The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.
NCT03047447
Original research article entitled Induced and Controlled Dietary Ketosis as a Regulator of Obesity and Metabolic Syndrome by Madeline Gibas for consideration for publication in a clinical journal. This research manuscript builds on previous landmark studies that report that major weight and fat mass loss in type II (T2D) patients who were fed a very low carbohydrate, ketogenic diet. In this manuscript, the investigators outline our research study that showed statistically significant (p \< 0.05) changes over time in hemoglobin A1c, weight, BMI, body fat percentage and ketones for patients with metabolic syndrome who were fed a very low carbohydrate diet, ketogenic diet.
NCT00835861
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy. Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
NCT02358668
This is a single-centre, 16-week, randomized, double-blind, placebo-controlled, 3-treatment arm pilot study to evaluate the efficacy and safety of BTI320 in the treatment of high risk subjects with pre-diabetes. This is a pilot study aiming to test whether taking a medicine named BTI320 that slows down carbohydrate absorption in the gut, will lower blood sugar. The study aims to recruit 60 individuals in Hong Kong. To take part in the study, subjects must have pre-diabetes, that is, they have blood sugar levels that are above normal but not reaching diabetes range. The medicine BTI320 is currently licensed as a health supplement in Hong Kong and is known alternatively as SUGARDOWN®. The investigators are comparing the effectiveness of BTI320 against a dummy tablet. Both tablets look and taste identical and during the study, subjects will not know which of these tablets they are taking. There is a 4 in 5 chance of receiving active medication and 1 in 5 chance of receiving placebo. Subjects will be followed up closely every 2 to 4 weeks for a period of time up to 22 weeks. The study visits will take between 30 minutes to 3 hours, depending on additional checks that are required on a particular visit including oral glucose tolerance test and meal tolerance test. At visits involving meal tolerance test, subjects will be required to stay for approximately 3 hours. In addition, at Visit 2, Visit 4 and 3 days before Visit 7, a continuous glucose monitoring system device will be installed. Throughout the study period, subjects will return to the study center for check-ups including careful enquiry about whether they have developed any side-effects from taking the medication, physical examination, as well as blood tests.