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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02461394 Completed - Diabetes Clinical Trials

User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013

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

The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8. The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS. For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects. The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).

NCT ID: NCT02460783 Completed - Obesity Clinical Trials

Intermittent Calorie Restriction, Insulin Resistance, and Biomarkers of Brain Function

Start date: June 22, 2015
Phase: N/A
Study type: Interventional

Background: - Insulin removes sugar from the blood to use for energy. Insulin resistance means that cells may not respond to insulin normally. It can lead to serious diseases. Researchers want to see how diet affects insulin resistance, weight, and brain chemicals related to Alzheimer s disease. Objectives: - To compare two forms of diet and their effects on insulin resistance and the brain. Eligibility: - Women ages 55 70 with insulin resistance. Design: - This study requires 6 clinic visits over 9 12 weeks. Participants must fast before visits. - Visit 1, screening: - Medical history, physical exam, and blood and urine tests. - Participants will get a wrist device to wear for 4 days. - Visit 2: - Weight and waist measurement. - Blood drawn. - Questionnaires and thinking tests. - Lumbar puncture. Skin will be numbed and a needle inserted between bones in the back will remove <TAB>fluid. - Participants will drink a nutrition shake. Blood will be taken 12 times over 4 <TAB>hours through a thin tube in <TAB>the arm. - Brain MRI. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. <TAB>They will have a coil on their head and may do tasks. - Participants will get advice about healthy eating and be randomly put in one of 2 groups. One group will get <TAB>nutrition shakes to drink. - Visits 3 5: - Weight and waist measurements, vital signs, blood draw, and questionnaires. - Between visits, participants will get a call or email to check how they are doing. - Visit 6: Repeat of visit 1. - Participants will wear the wrist device for 4 more days, have a follow-up contact, then the study is finished.

NCT ID: NCT02460718 Completed - Diabetes Mellitus Clinical Trials

ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama

ENCOURAGE
Start date: February 2009
Phase: N/A
Study type: Interventional

It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.

NCT ID: NCT02459535 Completed - Diabetes Clinical Trials

Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1

ILIAS-1
Start date: March 2015
Phase: N/A
Study type: Interventional

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes. Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release. However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial. The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.

NCT ID: NCT02458495 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Diabetes Medication Adherence Promotion Intervention Trial

Diabetes MAP
Start date: August 2015
Phase: N/A
Study type: Interventional

A significant percentage of persons with diabetes fail to properly take their prescribed oral hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients is associated with poor health outcomes including suboptimal glycemic control, diabetes-related complications, elevated health costs and increased risk of hospitalization and mortality. Given the substantial impact of non-compliance on the health of patients, prior studies have sought to draw links between medication adherence and patient factors. Research shows that web-based interventions that support patients' medication-related knowledge, motivation and skills effectively improve compliance. The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered medication adherence promotion intervention on medication adherence and glycemic control among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge, motivation and skills. This research will greatly enhance the investigators' understanding of medicine compliance and the factors that effectively improve adherence among high-risk patients with diabetes. Knowledge gained from this work may inform future internet-based patient portals that support disease management and medication adherence more broadly.

NCT ID: NCT02458027 Completed - Obesity Prevention Clinical Trials

Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2

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

The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

NCT ID: NCT02457897 Completed - Diabetes Mellitus Clinical Trials

Thyroid Hormone to Induce Non-Insulin Mediated Glucose Disposal in People With Insulin Receptor Mutations

Start date: April 17, 2015
Phase: Phase 2
Study type: Interventional

Background: - Insulin receptor mutation causes high blood sugars and sometimes diabetes complications. Researchers want to see if thyroid hormone helps. Objectives: - To see if thyroid hormone treatment changes how the body handles sugar in people with insulin receptor mutation and improves blood sugar in people with diabetes. Eligibility: - People ages 12 65 with an insulin receptor mutation. Design: - Study part 1:19-day clinic stay. Participants will be monitored for 4 days. Then for 15 days they will take a thyroid hormone pill 3 times a day. Participants will have: - Blood tests. - Heart rate and skin temperature monitored. - All their food provided. - Two 5-hour sessions in a special room. They will wear special clothes and sometimes sit still. - Two small tubes inserted in veins. One will deliver tiny amounts of sugar and fat with a non-radioactive tracer. Participants will also drink water with a tracer. The other tube will collect blood. - A sweet drink. Participants may have finger stick blood sugar tests. - Glucose-monitoring device inserted into body fat for two 24-hour periods. - Adults may have samples of fat and muscle taken. - Heart ultrasound. - PET-CT scan in a machine. An intravenous catheter will be placed in an arm vein. A small amount of radioactive substance will be injected. - DEXA scan of body fat and bone density. - Participants with poorly controlled diabetes will then take thyroid hormone at home for 6 months. They will have blood drawn and sent to the study team monthly. - After about 3 months, they will have an overnight visit. After 6 months, they will have a 4-day visit.

NCT ID: NCT02456064 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus

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

The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.

NCT ID: NCT02455414 Completed - Diabetes Mellitus Clinical Trials

Tracking Neurodegeneration in Early Wolfram Syndrome

TRACK
Start date: April 2012
Phase:
Study type: Observational

The goal of this study is to determine the pattern of early neurodegenerative changes in WFS (Wolfram Syndrome). The investigator will perform cross-sectional and longitudinal assessments of youth with WFS, targeting sensitive neural systems with quantified neuroimaging and behavioral measures. In addition, the investigator will establish the utility of a WFS severity rating scale (WFS Unified Rating Scale or WURS). Preliminary data support the feasibility of this approach and its potential to generate important new information about neurodevelopmental and neurodegenerative patterns in WFS. This work is necessary to position the field for future clinical trials to test interventions for WFS neurodegeneration. Ultimately, a better understanding of the trajectory of neurodegeneration in WFS and the development of effective interventions may be relevant to other more common neurodegenerative and endocrine (Type 1 and Type 2 diabetes) diseases in which ER stress has been implicated.

NCT ID: NCT02455011 Completed - Diabetes Clinical Trials

Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus

Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects. The study will be conducted at multiple sites in the United States and will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve, controlled with diet and exercise or treated with oral antidiabetic medications.