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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02257190 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Features Behind the Beneficial Effects of Interval-walking

aIWS2
Start date: October 2014
Phase: N/A
Study type: Interventional

A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The reason IW is superior is unknown. This study will look into whether it is the larger peak intensity during IW or if it is the alternating exercise pattern that is responsible for the larger improvements seen. Subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions: 1. One hour of rest (Con) 2. One hour of classical interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW3) 3. One hour of fast alternating interval walking (repeated cycles of 1 min of fast and 1 min of slow walking; IW1). After the interventions subjects will undergo a standardized mixed meal tolerance test, with consecutive measurements of blood glucose, insulin and c-peptide.

NCT ID: NCT02256332 Completed - Clinical trials for Diabetes Mellitus, Type 2

Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes

Start date: January 2015
Phase: N/A
Study type: Interventional

Effects of a plant based ingredient on blood glucose in Type II diabetes patients.

NCT ID: NCT02255682 Completed - Diabetes Mellitus Clinical Trials

Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being

LIFESTAT
Start date: January 2015
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. 600,000 people in Denmark are taking statins on a daily basis, 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 prevent) physical exercise training? Furthermore we would like to answer the following questions: 1. Does statin treatment impair (or even prohibit) physical exercise training? 2. Does statin treatment cause: - Decreased muscle strength? - Skeletal muscle inflammation? - Decreased mitochondrial respiratory function? 3. Abnormal glucose homeostasis?

NCT ID: NCT02255266 Completed - Clinical trials for Diabetes Mellitus, Type 2

Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Start date: March 26, 2015
Phase:
Study type: Observational

This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.

NCT ID: NCT02254291 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

SUSTAIN™
Start date: October 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

NCT ID: NCT02252965 Completed - Clinical trials for Diabetes Mellitus, Type 2

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes (CONSENT)

CONSENT
Start date: December 2014
Phase: Phase 4
Study type: Interventional

This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).

NCT ID: NCT02250677 Completed - Diabetes Mellitus Clinical Trials

LIFESTAT - Living With Statins, a Cross Sectional Study

Start date: April 2014
Phase: N/A
Study type: Observational

Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of cardio-vascular diseases (CVD). The use of statins has increased markedly and it is now one of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily basis, 40 % of these are taking the medication without having any other risk factors for CVD 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 CVD, 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 we would like to answer the following questions: a Does statin treatment impair (or even prohibit) physical exercise training? b Does statin treatment cause: - Decreased muscle strength? - Skeletal muscle inflammation? - Decreased mitochondrial respiratory function? c Abnormal glucose homeostasis?

NCT ID: NCT02249910 Completed - Healthy Clinical Trials

Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

Start date: September 18, 2014
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.

NCT ID: NCT02249897 Completed - DIABETES Clinical Trials

PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs

PREL-AGES
Start date: January 2015
Phase: Phase 4
Study type: Interventional

There is evidence of the association between diabetic microangiopathy and elevated serum concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with ingestion of specific foods (baked meats and milk powder); reducing their dietary intake lowers AGEs concentrations, with beneficial metabolic effects; however threre is still no evidence of whether this has an impact on microvascular complications of DM. We recently applied for funding to compare in a RCT the effects of Cholestyramine versus placebo, on visual electrophysiology. This drug is similar to Sevelamer in structure, both act as chelators of bile salts, and reduce absorption of dietary AGE, lowering serum levels. However it is essential to carry out preliminary tests to assess aspects that may imply adjustments to the proposed protocol, such as: 1) tolerance to the drug 2) short term effect of the drug versus placebo on serum levels of AGEs 3) effects of the drug versus placebo in levels of fat soluble vitamins (D and K specifically) 4) intra and interindividual variability of electrophysiological measurements of vision (ERGMF and optic nerve conduction velocity) 5) drug versus placebo in electrophysiological measurements of vision (neuroconduction ERGMF and optic nerve). Objective: The present project is planned as a pilot study, which will clarify points 1 to 5. Methodology: patients (6 DM2, 25 -50 y) will be assessed through anthropometry, clinical laboratory tests (creatinine, chemistry profile, lipid profile, microalbuminuria glycosylated hemoglobin, vitamin B12, 25OH vitamin D and prothrombin), dietary recalls specifically designed to analyze the regular consumption of AGEs, serum CML and neuro-ophthalmological study (fundus, ERGMF and optic nerve conduction). Subsequently each patient will be assigned to treatment with placebo for 3 months and then Cholestyramine 6 g / day for 12 weeks and at the end of each period will be reassessed using the same methodology. If patients cannot tolerate the drug, they will be assigned to a reduced AGE diet. Expected results: Cholestyramine will have side effect similar to placebo (mainly digestive). The active drug and not placebo will reduce serum levels of AGEs and electrophysiological parameters of vision at 12 weeks. It is expected that a low AGEs diet in patients who do not tolerate the drug will also reduce serum CML although to a lesser degree and will also induce electrophysiologic changes.

NCT ID: NCT02249871 Completed - Healthy Clinical Trials

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Start date: September 24, 2014
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healthy subjects.