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NCT ID: NCT03374774 Enrolling by invitation - Diabetes Clinical Trials

A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)

Start date: November 13, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to collect information about the participant's ability and willingness to pay for NovoMix 30 using a modern device, which is prescribed to the participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical practice. The study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or Penfill has been made independent from this study.

NCT ID: NCT03374098 Not yet recruiting - Diabetes Clinical Trials

Pilot of Home Visitation Services for Patients With a Diabetes Diagnosis

LMC-PCMH-H
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This pilot program will assess whether an enhanced PCMH model with more intensive management and intervention can improve chronic disease patient outcomes, improve healthcare delivery, and reduce healthcare costs. Participants in this program are current patients at Leland Medical Clinic and are either enrolled, or eligible to enroll, in Mississippi's Medicaid program. This pilot program will test the effectiveness of high-quality interventions comprising of: (1) an educational intervention focusing on chronic disease management and (2) home visits by a trained community outreach worker. This pilot program will evaluate both process measures and outcome measures. Examples of process measures include, but are not limited to, the number of patients enrolled in each intervention group, the number of educational classes attended by a unique patient, and the number of home visits a unique patient receives. Examples of outcomes measures include, but are not limited to, change in patient HbA1C levels, change in patient LDL/HDL levels, change in patient blood pressure (systolic and diastolic) levels, and a comparison of patient cost data (total expenditure, expenditures by other major categories like hospital, pharmacy, etc.) After baseline measurements, patient clinical values will be acquired every 3 months for the duration of their engagement. This pilot project has three specific goals: Goal 1: Improve healthcare delivery for chronic disease patients enrolled in Mississippi Medicaid. Goal 2: Improve clinical outcomes for chronic disease patients enrolled in Mississippi Medicaid. Goal 3: Reduce Mississippi Medicaid costs for chronic disease patients enrolled in this pilot program.

NCT ID: NCT03371303 Active, not recruiting - Diabetes Clinical Trials

Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects

PHMEV
Start date: November 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The modifications of the medicinal treatments secondary to the hospitalizations have multiple reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities, potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet, classification in reserve or hospital prescription ... These modifications are potentially generating extra costs for the Health Insurance and are monitored under the terms of the Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical rationale of the treatment changes imposed by hospitalization in a university-hospital center, their influence on the security of the medical treatment of patients and their financial implications for healthcare organizations

NCT ID: NCT03370497 Recruiting - Obesity Clinical Trials

Calcium-protein Co-ingestion and Gut Hormones

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

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.

NCT ID: NCT03370484 Recruiting - Obesity Clinical Trials

Calcium and Gut Hormones

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

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.

NCT ID: NCT03368209 Terminated - Diabetes Clinical Trials

Noninvasive Glucose Measurements - Database and Calibration Compilation

Start date: December 4, 2015
Phase: N/A
Study type: Interventional

This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.

NCT ID: NCT03367663 Not yet recruiting - Diabetes Clinical Trials

The Effect of Prednisone on Atherogenesis as Studied in the Macrophage Foam Cell Formation Model System.

Start date: December 2017
Phase: Early Phase 1
Study type: Interventional

Glucocorticoids (GCs) are a class of endogenous steroid hormones produced by the adrenal glands and controlled by the hypothalamic-pituitary-adrenal axis (HPA). One of the mechanisms of their action is achieved through ligand-receptor attachment to a class of cytosolic steroid hormone receptors termed Glucocorticoid Receptors (GRs). The formed ligand-receptor complex is a transcription factor involved in gene activation of anti-inflammatory products or repression of pro-inflammatory products [1]. Synthetic forms of GCs are a group of anti-inflammatory and immunosuppressive medications (e.g. Prednisone) that are widely used in clinical practice to treat inflammatory diseases (e.g. Rheumatoid Arthritis, Vasculitis, Asthma). The effectiveness of this class of drugs is limited by numerous adverse effects that include, but not limited to, insulin resistance, glucose intolerance, dyslipidemia, and hypertension, all of which are well known risk factors for cardiovascular diseases (CVD) [2,3]. Furthermore, recent research suggest that inflammation has a key role in development of CVD and can predict prognosis [4]. Inflammatory cells have an important role in the development of atherosclerotic lesion in the arteries. Blood monocyte-derived macrophages are involved in this process, and they infiltrate the lesion where they take up various forms of lipids (cholesterol - rich LDL, and oxidized LDL) as well as triglycerides - rich VLDL), followed by the formation of lipid-laden foam cells, the hallmark of early atherogenesis. Inflammatory cells and molecules as well as proteolytic enzymes secreted from inflammatory cells in the atherosclerotic lesion, have a central role in destabilizing the plaque (vulnerable plaque) leading to its rupture, which, in turn, induces thrombosis, and initiating acute coronary events [4,5]. Based on our understanding of the involvement of inflammation in the early development of atherosclerotic lesion, and our experience with the anti-inflammatory effects of synthetic GCs, a hypothesis emerged suggesting this class of drugs as a way to inhibit early atherosclerotic plaque formation, and to attenuate CVDs [6]. Research results in this field are surprising because while glucocorticoids treatment in humans increase the risk of CVDs [6,7,8,9], animal models shows the opposite, atheroprotection was shown in rabbits [10,11,12] and mice [13,14,15]. This paradox may be explained partially by the fact that clinical studies in this field are mainly conducted in patients with predisposing factors to develop CVD, either because of pre-existing traditional risk factors like Diabetes and Hyperlipidemia, or because of the pre-existing medical condition they are being treated for with GCs (e.g. Rheumatoid Arthritis). Mechanism based research to study the effects of GCs on atherogenesis, without confounding factors, is lacking. Only few studies were performed on GCs in healthy subjects but none of them explored their effects on foam cell formation [16,17]. Our study thus aims to further our understanding of the role of specific glucocorticoid, prednisone, in the process of atherogenesis. In order to achieve that we plan to study the following: 1. The effects of five days of treatment with prednisone on serum lipid concentration and oxidative stress. 2. an Ex-vivo study is planned where the serum of healthy human subjects treated with Prednisone, will be introduced to J774A.1 murine macrophage-like cell line, a well-studied macrophage foam cell formation model.

NCT ID: NCT03367455 Completed - Diabetes Clinical Trials

Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

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

The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.

NCT ID: NCT03366168 Recruiting - Diabetes Clinical Trials

Taste Bud-Derived Stem Cells in Humans

Start date: December 20, 2017
Phase: N/A
Study type: Observational

Background: Stem cells are found in body tissues. They can regenerate into more of the same cells or become other types of cell. Researchers want to use stem cells from taste buds to try to make cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue. Researchers also want to study if the number of taste buds and stem cells decrease as people age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes treatments. Objectives: To see if stem cells from taste buds can be isolated in humans. Eligibility: Healthy adults at least 18 years old Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests - Tongue photograph and mouth inspection. Food coloring will be applied to the tongue. Participants will have 1 study visit. They will not eat or drink anything 8 hours before. - They will give blood and urine samples. - They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth will be examined. The tongue may be cleaned. The tongue will be numbed. Five small pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with cotton and should stop in minutes. - Participants will be monitored for about 30 minutes. They will get a snack or meal. - They will be told how to take care of the tongue for the rest of the day. Participants will be called a week later to see how the

NCT ID: NCT03362528 Active, not recruiting - Diabetes Clinical Trials

Database and Calibration of a Non-invasive Glucose Monitoring Device

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.