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Prediabetic State clinical trials

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NCT ID: NCT04403789 Completed - Clinical trials for Cardiovascular Risk Factor

Effects of a Workplace Exercise Intervention on Cardio-Metabolic Health

Start date: March 28, 2021
Phase: N/A
Study type: Interventional

Background: The rising levels of physical inactivity in the Eastern Mediterranean region (43.2%) and in the United Arab Emirates (38%) compared with the global levels of physical inactivity (31.2%) is alarming (6,15). Therefore, action is required to reduce physical inactivity using evidence-based strategies. This study aims to provide scientific evidence that if the workplace environment promotes behavior change, physical activity levels could increase and, therefore, improve health. Objective: Primary objective: to determine whether the workplace exercise intervention will improve the cardio-metabolic risk components for the employees. Secondary objective: to determine whether the workplace exercise intervention will improve physical activity levels even after 4 weeks of completing the intervention. Methods: A total of 150 participants will be recruited from a semi-government telecommunication company after meeting the eligibility criteria; 75 will be assigned to the intervention group and 75 to the delayed intervention group. Intervention: The Intervention group will receive 2 hours of exercise per week during working hours for 12 weeks. One hour can be used per day. The intervention group will be assigned to attend personal trainer sessions in the workplace gym during the intervention. After the intervention is completed the delayed intervention group will also receive 2 hours of exercise time per week from working hours for 4 weeks. Expected results: There is a statistically significant difference in the primary and secondary health outcome between the intervention group and delayed intervention group. Expected conclusion: Increasing exercise time in the workplace is associated with favorable cardio-metabolic risk profile.

NCT ID: NCT04402710 Completed - PreDiabetes Clinical Trials

Is Teaching People to be Self-compassionate Feasible and Acceptable for People Who Are Pre-diabetic

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The investigators plan to examine the feasibility and acceptability of an online, two arm intervention ([self-compassion intervention + ideal care] versus [health information + ideal care]) designed to increase physical activity among individuals at risk of type two diabetes. The aim of the self-compassion intervention is to teach people at risk of type two diabetes how to use self-compassion (orientation to care for oneself during difficult situations) in order to help them self-manage and increase their physical activity. In a group, online format people at risk for type 2 diabetes will learn about their type 2 diabetes risk and strategies to increase their physical activity, which represents the recommended information that people at risk for type two diabetes should receive (i.e. ideal care). In addition to this, some participants, but not all, will be taught to be self-compassionate in relation to their type two diabetes risk and their efforts to increase their physical activity (i.e. intervention group). The other participants (i.e. control group) will instead receive general health information in addition to ideal care. Feasibility outcomes will be assessed using Thabane and colleagues (2010) model including the study's process, resources, management and scientific outcomes. In addition, qualitative exit-interviews with participants and research personnel will be conducted to assess the acceptability and feasibility of the intervention. Lastly, investigators will explore whether the intervention leads to changes from pre- to post-intervention in the secondary outcomes. This study is important as it will help inform and ensure the larger efficacy trial is of high quality.

NCT ID: NCT04401904 Completed - Aging Clinical Trials

SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

SGLT2i
Start date: June 25, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, blood pressure, and cardiac function. Based on these pleiotropic effects, including its calorie restriction-mimetic properties, the study team hypothesize that SGLT2 drugs will impact several basic aging-related processes, including reductions in oxidative damage to DNA and proteins, advanced glycation end products (AGE) and receptor for AGE (RAGE), cellular senescence, and mitochondrial function.

NCT ID: NCT04390373 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Prediabetes and Type 2 Diabetes Data Collection Study

T2Help
Start date: July 2020
Phase:
Study type: Observational

To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM, medication and food intake approximately 80% of the time for each subject that completes the entire active phase. In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes such as: - Sleep - Exercise/Physical activity/or lack of it - Heart rate - Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at screening and consent to the OGTT (Appendix 3) This data will address the sources and nature of blood glucose variability across the progression of PD and T2D. The data collected in this study will enable investigation into CGM-data artifacts that speak to the state and management of PD and T2D. Possible applications enabled by these data sets include: compliance with drug regimens and other lifestyle recommendations, drug titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the progression of the disease.

NCT ID: NCT04375449 Completed - Prediabetic State Clinical Trials

Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects

Start date: May 4, 2020
Phase: N/A
Study type: Interventional

The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.

NCT ID: NCT04364087 Completed - Diabetes Clinical Trials

Impaired Glucose Tolerance in Vietnamese Infertile PCOS Women

Start date: June 1, 2020
Phase:
Study type: Observational

Polycystic ovary syndrome (PCOS) is a common endocrine and reproductive disorder in which insulin resistance (IR) is proposed as a key pathophysiological feature of the disease's symptoms and consequences. Diabetes and rediabetes, a significant consequence of IR, are related to a higher risk of diabetes mellitus, future cardiovascular events, and adverse pregnancy outcomes.

NCT ID: NCT04343872 Completed - Pre-diabetes Clinical Trials

Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.

NCT ID: NCT04342624 Completed - PreDiabetes Clinical Trials

Investigation of Cinnamon Spice on Glucose Tolerance in Subjects With Pre-diabetes

CINNII
Start date: April 14, 2021
Phase: N/A
Study type: Interventional

This study aims to determine whether the effectiveness of cinnamon spice capsules vs. placebo capsules on glucose tolerance in prediabetic subjects who are overweight or obese.

NCT ID: NCT04341571 Active, not recruiting - PreDiabetes Clinical Trials

Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.

Start date: October 24, 2019
Phase: Phase 2
Study type: Interventional

Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment. The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.

NCT ID: NCT04335513 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D

TESS
Start date: April 30, 2020
Phase: N/A
Study type: Interventional

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.