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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03584217 Not yet recruiting - Obesity Clinical Trials

Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study

Start date: July 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Hyperfiltration is common in youth with T2D, and predicts progressive DKD. Hyperfiltration may also be associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Despite the high prevalence and gravity of DKD in youth-onset T2D, widely effective therapeutic options are lacking. The investigators' preliminary data support a strong association between IR and hyperfiltration in youth-onset T2D, but the pathology contributing to this relationship remains unclear. A better understanding of the pathophysiology underlying hyperfiltration and its relationship with IR is critical to inform development of new therapeutics. The investigators' overarching hypotheses are that: 1) hyperfiltration in youth-onset T2D is associated with changes in intrarenal hemodynamics, resulting in increased renal oxygen demand, 2) the demand is unmet by the inefficient fuel profile associated with IR (decreased glucose oxidation and increase free fatty acid [FFA] oxidation), resulting in renal hypoxia and ultimately renal damage. To address these hypotheses, the investigators will measure peripheral insulin sensitivity, adipose insulin sensitivity (FFA suppression), glomerular filtration rate (GFR), RPF, and renal oxygenation in youth with T2D (n=30), obesity (n=20) and in lean (n=20) controls.

NCT ID: NCT03583593 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Start date: May 23, 2014
Phase: Phase 2
Study type: Interventional

Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.

NCT ID: NCT03581266 Completed - Clinical trials for Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics

Glucose Kinetics After Wheat and Rye Breads

Start date: June 1, 2015
Phase: N/A
Study type: Interventional

Certain functional properties of cereal products, e.g. their postprandial glucose and insulin responses, have been characterized as steps towards obtaining a greater understanding of their beneficial health effects. A low-glycemic index diet results in decreased postprandial insulin and glucose responses, which is thought to be beneficial for insulin and glucose metabolism. In healthy subjects, it has been shown that rye breads (RBs) produce a lower postprandial insulin response compared with refined wheat breads (RWB) despite similar glucose responses. Juntunen et al. (2003) suggested that the difference in the structural characteristics between rye and wheat breads is a possible explanatory mechanism. However, the underlying mechanism of this discrepancy between insulin and glucose responses to rye bread, the so-called "rye factor" (RF), is still largely unknown. Faster starch digestibility and higher postprandial insulin responses for RWB compared with RBs may indicate faster intestinal glucose absorption and faster glucose disappearance respectively. Therefore our hypothesis is that despite having similar glucose responses, RWB has faster turn over (kinetics) compared with RBs. The present study is aiming to apply an experimental set up which can comprehend the hypothetical differences in RWB and RBs kinetics.

NCT ID: NCT03580967 Not yet recruiting - Clinical trials for Major Depressive Disorder

Vortioxetine Monotherapy for Major Depressive Disorder in Type 2 Diabetes

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

This study will enroll participants who have been diagnosed with type 2 diabetes and are experiencing symptoms of depression. This study will look at an anti-depressant medication called vortioxetine (Trintellix). Vortioxetine is an oral medication (pill) that has been approved by the US Food and Drug Administration (FDA) to treat depression in adults. The purpose of this study is to look at what effects (if any) vortioxetine may have on symptoms of depression in patients with type 2 diabetes. This study will also look at what effects (if any) vortioxetine has on blood sugar, and how vortioxetine may improve the way our brains are able to adapt and respond to stress.

NCT ID: NCT03579420 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The study will compare two different programs for lifestyle intervention in type 2 diabetes: 1. A brief group program, with three weekly sessions 2. A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years. The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.

NCT ID: NCT03578991 Not yet recruiting - Clinical trials for Diagnosed of Type 2 Diabetes in Active Treatment (Hypoglycemic Agents) for a Period =5 Years

Diabetes as an Accelerator of Cognitive Impairment and Alzheimer's Disease

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This randomized controlled trial is aimed at studying the effects of an eHealth intervention on improving metabolic control and other cardiovascular risk factors (obesity, lipidic profile and hypertension) as the approach to prevent or delay the process of cognitive impairment, and to reduce conversion rates to Alzheimer's disease (AD) in a sample of patients diagnosed of type 2 diabetes mellitus (T2D) and with mild cognitive impairment (MCI). For these purposes, the standard clinical treatment for this type of patients will be compared with two types of interventions (parallel groups): one aimed at promoting adherence to treatment through the use of a smart pillbox; and the other intervention will be based on the use of the smart pillbox plus and interactive digital platform allowing communication between patients and caregivers with healthcare professionals. Both interventions are targeted to improve adherence to treatment. The hypothesis is that the rate of conversion from MCI to AD will be higher in the control group than in the intervention groups (higher conversion rates are expected in control group, followed by the smart pillbox group, and lower conversion rates are expected in the group using the interactive digital platform and the smart pillbox).

NCT ID: NCT03577184 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.

Start date: July 2018
Study type: Observational

To evaluate the changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin.

NCT ID: NCT03576430 Recruiting - Clinical trials for Diabetes Mellitus, Type 2, Stress

The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment

Start date: June 25, 2018
Phase: N/A
Study type: Interventional

Type 2 diabetes (DM2) I may be associated with low level of Quality of Life (QOL), depression, persistent stress and autonomic nervous system dysfunction (ANSD). A new biological measure measuring the Pressure Pain Sensitivity (PPS) of the chest bone has been found to be a marker for persistent stress and ANS function, and linked to depression, QOL, chronic inflammation and HbA1c. An intervention which uses the PPS measure as a biological feedback marker for stress reduces the level of persistent stress (PPS) and depression, reduces blood pressure, serum lipids, restores ANSD and increases quality of life. Objectives: primary: if a simple individualized self-care based intervention, using the PPS of the chest bone as a biofeedback marker for stress, reduces PPS and with concomitant reduction in HbA1c. Secondly, if changes in PPS and HbA1c correlate, if the level of depression and number of clinical stress symptoms are reduced, and QOL and personal empowerment increased. Thirdly, if use of glucose-lowering medication, blood pressure, heart rate, work of the heart, autonomic nervous system dysfunction measured by PPS and cardiovascular response to tilt table test and heart rate variability, serum lipids and low-grade inflammation are reduced. As a separate part of the study, the implementation aspects of the PPS guided intervention are studied. Design:RCT,single-blinded, 1:1 randomization, in which diabetic treatment as usual (TAU) is compared to TAU plus a self-care based intervention program based on daily PPS measurements at home over a 6 months period and daily 2 times nervestimulation as mandatory. The study will be open to the patient and the treating professionals but blinded towards the evaluating researchers. The implementation part of the study will be conducted according to WHO guidelines. Patients: 160 patients with DM2 from primary health care. Effect variables: Primary: HbA1c. Secondary : PPS, depression, QOL, personal empowerment, and the correlation between changes in PPS and HbA1c. Treatment: All patients receive diabetes care as usual. The active group receives in addition the self-care based, non-pharmacological PPS guided intervention program, which focuses on daily PPS measurement for cognitive reflection and cutaneous sensory nerve stimulation for reduction of PPS with the aim to reduce the elevated PPS.

NCT ID: NCT03576300 Recruiting - Clinical trials for Diabetes Mellitus Type 2

Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome

Start date: February 1, 2018
Study type: Observational

The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes

NCT ID: NCT03575988 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients

Start date: July 3, 2018
Study type: Observational [Patient Registry]

Current knowledge: To the best of our knowledge, no studies have reported the correlation between pulmonary function and the vascular endothelial function in diabetic patients during the preclinical period. Indeed, diabetic nephropathy and retinopathy are the leading causes of end-stage renal failure and acquired blindness, respectively. However, when investigators treat patients with type 2 diabetes, investigators seldom consider the pulmonary vascular injury induced by glycemia. Experimental studies have shown that pulmonary function and Vascular endothelial function change during the preclinical stages of diabetic retinopathy. Researchers have already established that compared to healthy subjects, patients with type 2 diabetes have a reduced alveolar gas exchange capacity. The NO and ET-1 can be used to assess the Vascular endothelial function. What this paper contributes to our knowledge: Regulating glycemia can improve Vascular endothelial function . This study suggests that detecting the NO and ET-1 would allow for the prediction of changes in pulmonary function during the preclinical stages of diabetic retinopathy and the degree of retinopathy in the future.