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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02796378 Active, not recruiting - Diabetes Mellitus Clinical Trials

Living With Statins - Interventional Exercise Study

LIFESTAT
Start date: June 2016
Phase: Phase 4
Study type: Interventional

Background. Statins are cholesterol lowering drugs that are prescribed to lower the risk of cardio-vascular diseases. The use of statins has increased markedly and it is now one of the most prescribed drugs in the world. More than 600,000 people in Denmark are taking statins on a daily basis, approximately 40 % of these are taking the medication without having any other risk factors for cardio-vascular diseases than elevated blood-cholesterol i.e. they are in primary prevention. Statins are not without side effects and studies have shown that there is an elevated risk of developing diabetes when taking statins. This has led to an increased debate about the use of statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years. These data suggest that more conservative use of statins to prevent CVD in otherwise healthy individuals at low risk for future CVD may be warranted. Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially can prevent a physically active lifestyle. The biomedical background of these side effects is not fully elucidated but it has been shown that there is a link to decreasing levels of an important enzyme, Q10, which plays a role in muscle energy metabolism. Hypothesis The overarching research question is: why does statin treatment cause muscle pain? Does statin treatment impair (or even prohibit) physical exercise training? Furthermore the following questions will be investigated: A. Does statin treatment cause: 1. Decreased muscle strength? 2. Skeletal muscle inflammation? 3. Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis? Re question A & B: If so, can physical training counteract this effect of statin treatment?

NCT ID: NCT02795910 Active, not recruiting - Hypertension Clinical Trials

Integrated Primary Care for Diabetes and Cardiovascular Disease

PACKBrazDCVD
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.

NCT ID: NCT02762695 Active, not recruiting - Hypertension Clinical Trials

Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile

Start date: May 4, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.

NCT ID: NCT02748434 Active, not recruiting - Diabetes Mellitus Clinical Trials

Glucose Variability in Subclinical Hypertrophy

Start date: October 2016
Phase: N/A
Study type: Interventional

Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.

NCT ID: NCT02744963 Active, not recruiting - Hypertension Clinical Trials

Carefully seLected and Easily Accessible at No Charge Medications

CLEAN-Meds
Start date: June 2016
Phase: N/A
Study type: Interventional

This trial evaluates the effect of providing primary care patients with free and convenient access to a set of essential medicines. Half of the participants will receive free and convenient access to these essential medicines, while the other half will have usual access to medicines.

NCT ID: NCT02731716 Active, not recruiting - Diabetes Clinical Trials

Transforming Primary Care Payment in Hawaii

Start date: April 2016
Phase: N/A
Study type: Interventional

To design an innovative payment system that improves upon fee-for-service (FFS), incorporates behavioral economic principles, and improves work satisfaction among primary care physicians (PCPs) while improving quality and reducing health spending at the state level. Second, to test the incremental effectiveness of two additional interventions: (1) shared financial incentives between physicians and poorly controlled diabetes and (2) social comparisons ranking physicians on quality metric performance and total cost of care.

NCT ID: NCT02716870 Active, not recruiting - Hypertension Clinical Trials

Meta-analyses of the Effect of Important Food Sources of Sugars on Cardiometabolic Risk Factors

Start date: June 2015
Phase:
Study type: Observational

Fructose-containing sugars have been implicated in the epidemics of obesity, diabetes and related cardiometabolic disorders. This view is supported by lower quality evidence from ecological observations, animal models, and select human trials. Higher level evidence from controlled trials and prospective cohort studies have been inconclusive. Whether sugars contribute to cardiometabolic complications independent of their calories remains unclear. To address the uncertainties, the investigators propose to conduct a series of systematic reviews and meta-analyses of the totality of the evidence from controlled trials to distinguish the contribution of fructose-containing sugars from that of energy in the development of markers of cardiometabolic risk. 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: NCT02710370 Active, not recruiting - Obesity Clinical Trials

Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in Humans

Start date: February 2016
Phase:
Study type: Observational

The purpose of this research study is to determine how gastric bypass surgery effects metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in animal models is change to the biology of the small intestine (Roux limb) and how glucose and other fuels are metabolized (or how the body digests and uses sugar and other fuels). This study will evaluate the role of the intestine in the beneficial metabolic effects of gastric bypass surgery. It specifically will examine whether the intestine increases its metabolism and its activity, and whether this results in an increase in fuel utilization. Thirty two (32) subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the time of gastric bypass surgery, a small piece of intestine that is usually discarded will be collected. At three time points over the first year after surgery, intestinal samples will be obtained by endoscopy or insertion of a lighted flexible tube through the mouth. Blood samples will be taken at all time points, as well. All samples will undergo comprehensive metabolic analyses. Comparisons will be made between the two groups to understand the metabolic changes over time and if there are differences between the two groups.

NCT ID: NCT02702440 Active, not recruiting - Obesity Clinical Trials

Systematic Review and Meta-analysis of Liquid Versus Solid Calories and Body Weight

Start date: May 2015
Phase: N/A
Study type: Observational

Consumption of sugar-sweetened beverages (SSBs) has been linked to rising rates of overweight and obesity. The most prominent mechanism to explain the link between SSBs and obesity is that liquid calories are not perceived by the body; thereby, promoting less satiety, less energy compensation and more weight gain than does the same energy consumed in solid form. This view is supported by pooled analyses of acute preload trials that have primarily measured food intake as the outcome. Though failure of short-term compensation has been observed with liquid calories, results from these acute preload trials should not be extrapolated to infer that liquid energy sources lead to weight gain over the long-term. To date, it is unclear whether liquid calories have differential effects than solid calories on body weight gain over the longer term. To increase clarity in this issue, the investigators propose to conduct a systematic review and meta-analysis from long-term controlled feeding trials to distinguish the contribution of liquid calories from solid calories on body weight over the long-term. The findings generated by this analysis will 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: NCT02702375 Active, not recruiting - Stroke Clinical Trials

Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases

Start date: September 2015
Phase: N/A
Study type: Observational

There is an urgent need for stronger evidence to support recommendations for the role of sugars in diabetes and related cardiometabolic diseases. Although large prospective cohort studies have shown a significant positive association of fructose-containing sugars-sweetened beverages with incident obesity, diabetes, heart disease, and stroke, these associations do not appear to hold true for total fructose-containing sugars and other important sources of free fructose-containing sugars such as pure fruit juice, yogurt, or even cakes and sweets. As dietary guidelines have moved away from macronutrient centric recommendations towards more food and dietary-pattern based recommendations, this inconsistency in the data has not been appreciated. There remains a focus on free sugars, in the absence of sufficient information on the role of different food sources of fructose-containing sugars in diabetes and related cardiometabolic diseases. A systematic review and meta-analysis of prospective cohort studies is considered to be the "Gold Standard" of evidence. To provide evidence-based guidance to support the development of public health policy in relation sugars and the primary prevention of diabetes, we will conduct a series of systematic reviews and meta-analyses of the relation of food sources of fructose-containing sugars with incident type 2 diabetes and related cardiometabolic diseases in prospective cohort studies.