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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02359214 Completed - Diabetes Clinical Trials

Effect of Vitamin D3 Supplementation on Cardiometabolic Risk

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

Supplementation studies with vitamin D have been performed where cardiometabolic risk markers have been assessed but these are few, and results are inconsistent. Hence, the purpose of this study is to determine: 1. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese adult participants for 8 weeks will significantly increase circulating concentrations of 25(OH)D or achieve optimal vitamin D status. 2. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardiometabolic parameters measured. 3. To evaluate the relationship between these variables and 25(OH)D concentration. We hypothesise that there will be a significant increase in plasma 25(OH)D following 8 weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg); Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardio metabolic parameters measured, and there will be a relationship between these variables and 25(OH)D concentrations.

NCT ID: NCT02358408 Completed - Diabetes Clinical Trials

System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

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

The study consists of 2 parts: The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.

NCT ID: NCT02358109 Completed - Diabetes Clinical Trials

The Flamenco (Fitness League Against MENopause COsts) Project

FLAMENCO
Start date: January 2014
Phase: N/A
Study type: Interventional

Spain is the second country in the world that consume more drugs. The average drug expenditure per capita in Andalucía during 2011 was 219.2 €. This drug spending increases during the perimenopausal period. According to the Study of the Economic Impact of Sport on Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro invested in sports promotion 50 euros are saved in health spending accumulated over 15 years. The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured objectively by accelerometry ) , functional capacity , quality of life and clinical profile of this population. iii ) To analyze the relationship between levels of physical activity / sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed at minimizing symptoms and health problems associated with the perimenopausal period will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per session ) for 16 weeks. With the analysis of the results of this project new patterns of objective work as well as the most significant practical resources for the design of a master plan may be determined. Results are expected to be able to shed some light on the implementation of programs of health promotion that are both time beneficial for the Andalusian Public Health and for the family , institutional and community economy.

NCT ID: NCT02357420 Completed - Diabetes Mellitus Clinical Trials

Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

Start date: January 29, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

NCT ID: NCT02357043 Completed - Diabetes Clinical Trials

User Performance Evaluation for DARIO™ BGMS

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

The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.

NCT ID: NCT02356848 Completed - Diabetes Clinical Trials

STEP UP to Avert Amputation in Diabetes

STEP UP
Start date: September 3, 2015
Phase: N/A
Study type: Interventional

This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.

NCT ID: NCT02356757 Completed - Diabetes Clinical Trials

Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy

PATRIOT
Start date: August 24, 2015
Phase: N/A
Study type: Interventional

The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose, blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher than normal risk for amputation. This novel intervention aims to improve self-care and early detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care using advanced behavioral approaches to target adherence to multiple health behaviors, including foot self-care, self-monitoring, medication adherence, dietary adherence, and physical activity simultaneously. If this promising behavioral theory-driven approach delivered using common technology (phone) to the patient at home can work in a setting where improvements in foot care are so urgent, it will be an important scientific contribution.

NCT ID: NCT02355158 Completed - Diabetes Clinical Trials

A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy

Start date: June 2014
Phase: Phase 2
Study type: Interventional

Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner.

NCT ID: NCT02352974 Completed - Clinical trials for Diabetes Mellitus, Type 1

GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)

DIAGNODE
Start date: January 2015
Phase: Phase 1
Study type: Interventional

The objectives of the main study is to: - Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen - Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion. The objective of the sub-study is to: - Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study - Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion.

NCT ID: NCT02352298 Completed - Diabetes Clinical Trials

Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

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

The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.