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Type 2 Diabetes clinical trials

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NCT ID: NCT01409239 Completed - Type 2 Diabetes Clinical Trials

Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes

Start date: July 2011
Phase: Phase 4
Study type: Interventional

Glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. However, it is unknown how modulation of glycemic variability would impact outcomes. One possibility is that glycemic variability could impact autonomic tone. In particular, heart rate variability (HRV) measurement is a sensitive marker for measuring autonomic tone, and aberrations in HRV have been associated with mortality. The current randomized pilot study will compare the effects of continuous intravenous (IV) insulin and subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic or are requiring at least 20 units of insulin per day will be included. Patients with conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms) will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24 hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ) insulin will receive basal bolus therapy using insulin analogues. All therapies will begin between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate variability. 1. Glycemic variability is associated with unfavorable changes in autonomic tone, as assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in overall glycemia. 2. Short-term increases in glycemic variability, followed by more prolonged glycemic stability are observed in generalized hospitalized patients treated with intravenous insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects receiving intravenous compared to subcutaneous insulin. 3. Glycemic variability differs among subjects receiving intravenous compared to subcutaneous insulin

NCT ID: NCT01408628 Completed - Type 2 Diabetes Clinical Trials

The I-KAN Study: Internet Insulin Education for Kansans

I-KAN
Start date: August 2011
Phase: N/A
Study type: Interventional

The primary purpose of the study is demonstration that teaching insulin management in small groups of type 2 diabetes patients in 4 weekly "live" Internet sessions is safe and provides an important resource for rural diabetes care providers who may otherwise, because of lack of time or staff, not be able to put patients on insulin who need it.

NCT ID: NCT01402388 Completed - Type 2 Diabetes Clinical Trials

Lifestyle Intervention in Patients With New Onset Type 2 Diabetes.

Start date: October 2007
Phase: N/A
Study type: Interventional

The study seeks to establish if weight loss achieved through a program of intensive lifestyle management can result in improvements in GLP-1 and glycaemic control, in patients with newly diagnosed type 2 diabetes mellitus.

NCT ID: NCT01399645 Completed - Type 2 Diabetes Clinical Trials

Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes

LIRAINS
Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty liver who are resistant to metformin, treatment with liraglutide in combination with metformin will cause an absolute reduction in liver fat superior to insulin-metformin treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).

NCT ID: NCT01397942 Completed - Type 2 Diabetes Clinical Trials

Maximising the Taste and Health Value of Plant Food Products

MAXVEG
Start date: May 2011
Phase: N/A
Study type: Interventional

To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake of mild and sweet modern vegetables or a normal western diet.

NCT ID: NCT01396564 Completed - Type 2 Diabetes Clinical Trials

Pioglitazone and Metformin in Diabetic Children

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D). MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent, as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin. STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t test. Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The statistical significance between variables is determined using ANOVA. The effect of confounding variables is analyzed with a test of co-variance analysis. Statistical significance is considered as p <0.05.

NCT ID: NCT01394510 Recruiting - Type 2 Diabetes Clinical Trials

Effect of the Anti-oxidant N-acetylcysteine on Beta-cell Function in Type 2 Diabetes

Start date: June 2011
Phase: N/A
Study type: Interventional

Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell dysfunction with oxidative stress proposed as a major mediator of this "glucotoxic" effect. High glucose levels have also been shown to contribute to vascular dysfunction and inflammation and these adverse responses decreased with the use of antioxidants. The hypothesis is that antioxidants improve beta-cell function in individuals with elevated glucose levels by decreasing oxidative stress. In this study the investigators will specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell function in individuals with type 2 diabetes by decreasing oxidative stress. This study will be a dose finding study to determine the tolerability of 600 mg versus 1200 mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative stress markers in persons with type 2 diabetes.

NCT ID: NCT01393808 Completed - Type 2 Diabetes Clinical Trials

Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes

PROCEED
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower is the disease progression in the long term. On the basis of the above findings, proteinuria has become a target of renoprotective therapy. Among different antihypertensive medications, those that inhibit the Renin Angiotensin System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce proteinuria and slow renal disease progression. Thus they have become the key component of renoprotective therapy in patients with proteinuric chronic kidney disease. Observational studies found that their effectiveness, however, is limited or even fully blunted in patients who eat large amount of salt. Experimental evidence indicates a renoprotective role of the vitamin D system in chronic renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor therapy. This effect, however, was largely restricted to subjects with daily sodium intake exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with paricalcitol appears to be effective in particular in those patients who do not appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is worth investigating. The broad aim of this study is to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy.

NCT ID: NCT01387334 Completed - Type 2 Diabetes Clinical Trials

The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients

RE
Start date: February 2007
Phase: Phase 2
Study type: Interventional

Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.

NCT ID: NCT01386671 Completed - Type 2 Diabetes Clinical Trials

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

COMET
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.