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Prediabetic State clinical trials

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NCT ID: NCT06040164 Not yet recruiting - Obesity Clinical Trials

Oral Endocannabinoids in People With Prediabetes and Diabetes

SMILE
Start date: October 1, 2023
Phase:
Study type: Observational

This study evaluates the relationship of endocannabinoids in saliva with inflammation and oral dysbacteriosis present in people with periodontal disease and prediabetes/type 2 diabetes

NCT ID: NCT06025292 Not yet recruiting - Pre Diabetes Clinical Trials

Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults

PORK
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.

NCT ID: NCT06005051 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Prediabetes Stratification by Multi-omics Profile After Food Intake

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

1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D. The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.

NCT ID: NCT05998460 Not yet recruiting - Prediabetes Clinical Trials

Glucose-Guided Eating Pilot

GET CHARGED
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

NCT ID: NCT05962983 Not yet recruiting - PreDiabetes Clinical Trials

Small Steps for Big Changes - Recipe for Health

RFH
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants two year after program completion compared to before they took part in the program. The main questions it aims to answer are: 1. Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels after SSBC program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)? 2. Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics (weight and waist circumference) after program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)? 3. Are eating motives associated with dietary intake in individuals with prediabetes? 4. Does participation in SSBC result in changes to eating motives over time? It is hypothesized that: 1. Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months post-intervention. 2. Dietary changes will be associated with weight and waist circumference at 3-, 6-, and 12-months post-intervention. 3. Participants' eating motives are associated with their dietary intake. 4. Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post intervention. A total number of 250 individuals with prediabetes will be recruited to take part in a 6-week diet and exercise changes program (SSBC). The program will be administered and facilitated by the community facility trainers at YMCA locations. Participants will be asked to visit Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.

NCT ID: NCT05939349 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is an implementation of a community co-designed randomized controlled trial (RCT) with a delayed intervention control group focused of equity (i.e., including the target population in the intervention designed for them) in design, implementation, and evaluation. The project will be conducted in 3 phases. Phase 1 will involve formative research and PPR co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol and components, for which investigators will then request IRB approval. Phase 2 will involve the implementation of a delayed intervention RCT PPR. Data analysis and final reporting will be conducted during Phase 3. Specific Aims: In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription program (PPR) intervention that emphasizes health equity in a low-income population served by Griffin Hospital (GH) and/or Griffin Faculty Physicians (GFP). Hypothesis: Collaborating with our community partners on the design and implementation of a PPR will lead to a successful design and implementation of the PPR to our population of focus, as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality. Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored PPR in a low-income population served by GH and/or GFP. Hypothesis: The PPR designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (Hemoglobin A1C, weight/body mass index, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period. Evaluate the impact of a tailored PPR on healthcare cost among low-income participants with prediabetes or type 2 diabetes. Hypothesis: The successful implementation of the tailored PPR will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.

NCT ID: NCT05925933 Not yet recruiting - Pre-diabetes Clinical Trials

High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.

NCT ID: NCT05914857 Not yet recruiting - Clinical trials for Impaired Glucose Tolerance

Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization (WHO), and both include impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and a calibrated hemoglobin A1c (HbA1c) of between 5.7 and 6.4%. More than 30 % of the global population demonstrated one or more forms of prediabetic dysglycaemia. In general, approximately 70 % of individuals with IFG and/or IGT can expect to go on to develop clinical type 2 diabetes at some time in the future, and the risk increases with higher HbA1c levels and with higher BMI. Worse still, the prevalence of pre-diabetes is increasing worldwide, with a growing number of patients progressing to diabetes. Identification and treatment of pre-diabetic individuals is therefore crucial. Recent evidence suggested that preventing progression of pre-diabetes to diabetes is possible, and thus efficacious interventions for pre-diabetic individuals are the cornerstone of diabetes prevention. The current paradigm for diabetes prevention in high-risk individuals focuses on achieving moderate weight loss via dietary change and increasing physical activity. However, lifestyle-based weight-loss strategies may initially be successful, but difficult to achieve or maintain. In many cases, pharmacologic treatments may be needed to regulate blood glucose. Randomized clinical trials (RCTs) have verified the efficacy of metformin in preventing insulin resistance syndrome, along with the progression of microvascular diseases and heart attacks. Meanwhile, clinical experience and trial data have yielded almost no significant safety concerns for metformin. Nonetheless, it may cause discomfort for up to 25% of patients who experience diarrhea and nausea subsequent to its administration. For patients with a contraindication or intolerable adverse effects to metformin, Sodium Glucose Cotransporter 2 (SGLT-2) inhibitors with novel mode of action may be another alternative. Large clinical trials have not yet identified a substantial elevation in the frequency of adverse reactions related to SGLT-2 inhibitors when compared to the placebo group. Inhibition of SGLT-2 has some extra advantages for diabetes management over other therapeutic approaches. Firstly, the SGLT-2 is exclusively expressed in renal proximal tubules, and thus selective inhibitors will exert a glucose-lowering effect, independently of insulin secretion. Therefore, SGLT-2 inhibitors can cause weight loss without inducing major hypoglycemic events. Secondly, the cardiovascular benefits of SGLT-2 inhibitors was supported by large clinical trials in the modern context of antiplatelet, statin, and blood pressure management, which may match many of the advantages of metformin. Thirdly, SGLT-2 inhibitors have also been proven to prevent nephropathy for its restriction on albuminuria and inflammatory processes, and to subsequently dampen the deterioration in renal function. Overall, SGLT-2 inhibitors have demonstrated safety in non-diabetic patients, particularly in those afflicted with heart or kidney failure, and have shown to provide additional benefits. At present, the overall effectiveness and safety of SGLT-2 inhibitors in improving metabolism of pre-diabetic patients are still unclear. The purpose of this experiment is to evaluate the effect of SGLT-2 inhibitor on pre-diabetic patients.

NCT ID: NCT05829239 Not yet recruiting - Obesity Clinical Trials

ADI-PEG20, Obesity and Prediabetes

Start date: July 2024
Phase: Phase 2
Study type: Interventional

Th purpose of this study is to determine whether ADI-PEG20 (PEGylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.

NCT ID: NCT05701813 Not yet recruiting - Obesity Clinical Trials

The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.

ONIRICO
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The study aims to investigate the effects of oral inositols on insulin-resistance and metabolic variables (triglycerides, total cholesterol, HDL cholesterol) in children aged 8-12 years with obesity and insulin-resistance.