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Prediabetic State clinical trials

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NCT ID: NCT05058690 Not yet recruiting - Diabetes Mellitus Clinical Trials

Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans

ACRE-CT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

NCT ID: NCT04786418 Not yet recruiting - Obesity Clinical Trials

Low-Calorie Diet in People With Prediabetes/Metabolic Syndrome

CALIBRATE
Start date: April 2021
Phase: N/A
Study type: Interventional

Significant weight reduction, achieved by low-calorie diet (LCD), will mobilise ectopic fat (visceral and particularly liver fat), improving insulin sensitivity and other metabolic syndrome components, with secondary beneficial effects on cardiac structure and function. This CALIBRATE study (metabolic, multi-organ and effects of low-calorie diet in younger obese patients with pre-diabetes) will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, anticipating at least 10% reduction in body weight. The investigators will examine how much the weight loss improves the metabolic abnormalities that precede type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease (CVD). This study will compare the effects of a safe and effective 12-month weight management intervention, initially using a low-calorie, liquid replacement diet for 12 weeks, followed by a weight maintenance phase. The investigators will examine how much the weight loss improves the metabolic and neuropathic abnormalities that precede and accompany type 2 diabetes (T2D), and in reversing the pre-clinical/subtle clinical abnormalities of the liver and heart that precede liver and cardiovascular disease. In an additional optional sub-study, the investigators will additionally assess how the weight loss impacts upon appetite regulation within the brain with functional MRI (fMRI).

NCT ID: NCT04555421 Not yet recruiting - Clinical trials for Overweight and Obesity

Using the Lumen Device for Prediabetes Prevention

Start date: October 2020
Phase: N/A
Study type: Interventional

To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes..

NCT ID: NCT04552002 Not yet recruiting - Dietary Supplements Clinical Trials

The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients

Start date: October 2020
Phase: Phase 3
Study type: Interventional

This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.

NCT ID: NCT04523363 Not yet recruiting - Clinical trials for Prediabetes; Complicating Pregnancy

Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Start date: June 1, 2025
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

NCT ID: NCT04494139 Not yet recruiting - Hypertension Clinical Trials

Acceptability, Feasibility and Effectiveness of a Worksite Intervention to Lower Cardiometabolic Risk in South Africa

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

As an important way to translate cardiovascular disease prevention efforts, worksite interventions can facilitate healthy food choices, health education, and social support. This proposed project is adapted and scaled-up from the Nepal study, and will measure the effectiveness of a canteen and a behavioral intervention on cardio-metabolic risk at a worksite in South Africa. This study will estimate the added benefit of a proven individual-level dietary intervention over environmental-level changes for preventing cardio-metabolic risk within the South African context. If the study demonstrates a significant effect, a scaled-up approach could produce an important reduction in cardiovascular disease burden through environmental and individual level prevention programs in South Africa.

NCT ID: NCT04442451 Not yet recruiting - Type 2 Diabetes Clinical Trials

Mechanisms of Fatigability With Diabetes

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Pre-diabetes (Pre-D) is a precursor to type 2 diabetes (T2D) and characterized by increased exercise fatigability of lower limb muscles, that can impede exercise performance. The cause for the increased fatigability in people with Pre-D is not known. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatiguing contractions of the lower limb muscles in people with Pre-D are limited by vascular dysfunction at multiple levels along the vascular tree including the artery, arteriole, and/or capillary. This clinical trial involves a novel exercise training regime involving blood flow restriction to the exercising limb will be used as a probe to further understand the vascular mechanisms for increased fatigability in people with Pre-D and T2D. The long-term goal is to better understand what limits exercise and functional performance in people with diabetes to help develop targeted, more effective exercise programs.

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: NCT04328363 Not yet recruiting - PreDiabetes Clinical Trials

Social Prescription and Lifestyles Modification to Reduce Glycemia in People With Prediabetes (PREDIBAL)

PREDIBAL
Start date: October 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the effectiveness and cost-utility of an intervention based on the social prescription of health assets to modify lifestyles and reduce blood glucose values in prediabetic patients in primary care nursing consultations. Multicentre, controlled and randomized (two different branches) clinical trial with 18 months of follow-up will be performed. The intervention group will receive a social prescription of health assets related to the practice of physical activity and healthy eating patterns in primary care nursing consultation.

NCT ID: NCT04131257 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal

NUCOD
Start date: December 2019
Phase: N/A
Study type: Interventional

The study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.