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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02600091 Completed - Depression Clinical Trials

Mindfulness-based Cognitive Therapy to Improve Emotional Wellbeing and Glycaemic Control in Diabetes

MILESTONE
Start date: October 30, 2015
Phase: N/A
Study type: Interventional

Type 1 and 2 diabetes are challenging conditions to manage. Anxiety and depression are common among this group and are associated with poorer diabetes control. No trials have been conducted to ascertain the effectiveness of psychological interventions designed to alleviate significant levels of anxiety and/or depression and improve glycaemic control among those with diabetes who have significant difficulties with their emotional wellbeing and diabetes control. The aim of this project is to establish if it is feasible to run a multi-site randomised controlled trial in Scotland exploring whether an 8-week mindfulness and self-management based intervention programme decreases anxiety and/or depression, and improves diabetes control. This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, and pave the way for a larger and definitive trial.

NCT ID: NCT02598986 Completed - Diabetes Clinical Trials

Effect of Macronutrient Supplementation on Glycemic Index of Pita Bread

Start date: June 2013
Phase: N/A
Study type: Interventional

Glycemic index (GI) of food is known to be positively associated with the development of several diseases including type 2 diabetes, cardiovascular disease and age-related macular degeneration. Modest dietary changes from high-GI foods to low-GI foods have shown beneficial effects. These findings have been translated to recommendations for increased dietary intake of whole grains. However, the inverse relationship between whole grain consumption and risk of the different components of metabolic syndrome has not been explained by their fiber content. Trials of added cereal fiber have failed to induce a protective effect and fiber has thus been proposed to be a marker of other components of whole grains that impart health advantages. Whole wheat grains are known to be a rich source of several minerals (phosphorus, potassium and magnesium) that play a role in glucose metabolism, and are depleted during the process of refinement. Thus, it is plausible to hypothesize that the benefits of whole grains previously ascribed to their fiber content are in fact due to these minerals. The proposed research aims to restore or fortify white bread with these minerals and determine the resulting glycemic index of mineral-fortified bread. With much evidence that most people prefer the taste and color of white bread, a low GI, mineral fortified white bread has the potential to reduce the risk of Metabolic Syndrome in those who consume it.

NCT ID: NCT02598544 Completed - Obesity Clinical Trials

Endocrine Regulation of Lipolysis in Obesity and Diabetes

ERLO
Start date: May 2013
Phase: N/A
Study type: Interventional

Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes. An important characteristic when examining AT function is the capacity to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.

NCT ID: NCT02597127 Completed - Diabetes Clinical Trials

Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)

ORION-1
Start date: January 2016
Phase: Phase 2
Study type: Interventional

This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of ALN-PCSSC injection(s).

NCT ID: NCT02596581 Completed - Diabetes Mellitus Clinical Trials

Chemerin and IL-6 Levels in Diabetes and Periodontitis

Start date: July 2014
Phase: N/A
Study type: Interventional

The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the GCF chemerin levels.

NCT ID: NCT02594033 Completed - Diabetes Clinical Trials

A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

Start date: October 27, 2015
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of the trial is to investigate different needle features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the trial drug in the body)

NCT ID: NCT02593032 Completed - Hypertension Clinical Trials

Effects of Use of a Connected Pillbox On Medication Adherence

(TVHST2DM)
Start date: February 2015
Phase: N/A
Study type: Interventional

Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Recent efforts to improve medication adherence in patients with multiple comorbidities have turned to case management and disease management programs. Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits and outreach. These devices enable frequent monitoring and intervention but can also generate large volumes of data that can be difficult for care teams to manage. The present study explores the use of one such device- a technology-enabled, connected pillbox. Given the continued emphasis on bending the cost curve in US healthcare, clinical validation of tools that may improve the management of costly chronic diseases, such as diabetes, is essential.

NCT ID: NCT02589873 Completed - Obesity Clinical Trials

Getting in Balance: A Workplace Diabetes Prevention Intervention Trial

GIBW
Start date: September 2015
Phase: N/A
Study type: Interventional

This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered using an online platform with lifestyle coaching support. Eligible participants will be randomized equally to each intervention program (120 participants in each).

NCT ID: NCT02589756 Completed - Obesity Clinical Trials

Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants

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

Obesity represents one of the most important public health challenges for the societies. Although excess energy intake and physical inactivity are major causes of obesity and cardiometabolic disorders, emerging evidence has linked persistent organic pollutants (POPs) with the global epidemic of type 2 diabetes. However, the potential impacts of POPs on obesity and cardiometabolic risk in humans remain poorly known. On the other side systematic reviews and meta-analyses conducted in recent years strongly support a protective association between eating nuts and CVD. The investigators will conduct a randomized controlled clinical trial in adults. The main research questions are: a. Does consumption of fatty fish increase levels of POPs in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? b. Does consumption of fatty fish affect markers of cardiometabolic risks (blood pressure, lipids, glucose and CRP) in overweight and obese adult norwegian men and women compared to a control group not consuming fatty fish? c. Does consumption of nuts improve markers of cardiometabolic risks in overweight and obese adult Norwegian men and women compared:1. to a control group not consuming nuts or fatty fish and 2. to a group consuming fatty fish. Clinical significance of study: If an increase in POP levels is seen, and correlates with cardiometabolic risks, this may indicate the need to look further at a causal relation between POPs and cardiometabolic disease and risk factors particularly type 2 diabetes. If eating nuts improves CVD risk factors compared to not eating nuts, or to eating fatty fish, this could be important dietary information for populations at high risk of CVD.

NCT ID: NCT02589639 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

Start date: October 28, 2015
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control