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Prediabetic State clinical trials

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NCT ID: NCT06237322 Not yet recruiting - Diabetes Clinical Trials

Study of RE.DOCTOR Vitals® Software Accuracy

RE-VITAL
Start date: March 1, 2024
Phase:
Study type: Observational

The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR Vitals software. The study aims to collect a diverse and extensive dataset of PPG waveforms, alongside traditional physiological measurements, for the purpose of enhancing existing algorithms and machine learning models used in health monitoring. The primary focus is on improving the accuracy and reliability of algorithms in interpreting PPG data to derive meaningful insights into physiological parameters. The main questions it aims to answer are: - How can extensive datasets of PPG waveforms be utilized to enhance existing algorithms and machine learning models? - How do correlations between PPG waveforms and key physiological parameters (such as glucose levels, blood pressure, heart rate, respiration rate) contribute to refining algorithms for more accurate and reliable health predictions? Participants will be asked to: - Continuously monitor their health using smartphone applications. - Allow the collection of PPG waveforms in diverse settings. - Engage in tasks related to monitor health parameters using medically approved devices

NCT ID: NCT06216340 Not yet recruiting - Weight Loss Clinical Trials

Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

Start date: February 15, 2024
Phase: Phase 4
Study type: Interventional

This trial is conducted in China. The purpose of the 24-week trial is to investigate the efficacy of henagliflozin to induce body weight loss and the purpose of the extension is to evaluate the hypoglycemic effect of henagliflozin in obese subjects without diabetes. Trial has the following two periods: 1) A 12-week randomized, double-blind, placebo-controlled, multi-center trial for evaluating the efficacy of henagliflozin to induce body weight loss; 2) A 12-week multicenter randomized controlled open-label trial for evaluating the hypoglycemic effect of henagliflozin followed by a 24-week extension period.

NCT ID: NCT06208189 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Is the Degree of Perceived Effort During Resistance Exercise Important for Improvements in Blood Glucose

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

The goal of this clinical trial is to compare the degree of effort during a resistance exercise session on blood glucose levels in individuals with prediabetes or type 2 diabetes mellitus. The main questions it aims to answer are: - Do individuals with prediabetes or type 2 diabetes mellitus need to perform resistance exercise with a high degree of effort for their blood glucose to improve? - How do they feel (their enjoyment, discomfort) after the sessions with different degrees of effort? Participants will perform 3 situations separated by at least 4 days, after being familiarized with all exercises and procedures: - One control day, when they will not exercise; - A high-effort resistance exercise session; - A low-effort resistance exercise session Researchers will measure blood glucose levels and psychological responses after these situations to see if the effort was important for the improvement of their blood glucose and how effort affected the way they felt after each situation.

NCT ID: NCT06195566 Not yet recruiting - Body Weight Clinical Trials

Development of PI-ML Algorithm for Prediction of the Real-time Risk for Developing Pre-diabetes

PRAESIIDIUM
Start date: January 29, 2024
Phase:
Study type: Observational

In this prospective, non-randomized, monocentric study, data will be collected from otherwise healthy individuals with overweight/obese grade I to increase data availability in the pre-diabetes field (impaired glucose intolerance), and to validate the outputs of an algorithm for the "physics-informed machine learning (PIML)" designed to estimate the real-time risk of prediabetes. Each participant will take part in the study for 4 months, including 3 onsite visits. During the screening visit, participants' eligibility will be determined by checking the inclusion and exclusion criteria after detailed information and obtaining informed consent by the investigator. Blood will be withdrawn for exclusion of existing prediabetes/diabetes at the fasted state. For women in reproductive age, a urinary pregnancy test will be performed. After getting the results of blood tests (glucose and HbA1c), participants will be asked to participate in study. On the visit 1, eligible participants will arrive at the study centre in a fasting state. Blood samples will be collected and participants will get vials and instructions for collection of stool and urine samples. Anthropometric data, lifestyle habit (cigarette, alcohol consumption) and family history will be collected. A 6-minute walking test to determine VO2 max will then be performed. Participants will receive a blinded Abbott Libre Pro glucose sensor, which they will wear for the next 14-days. Further, participants will be provided with a Fitbit Charge 5 health and fitness wristband. For validation purposes some part of study participants will be kindly asked to test newly develop wrist-worn device (EDIBit). With the help of 24-hour food recall, study subjects will be trained by medical staff on how to correctly enter their food intake in the Study app for completion of digital 3-day food diaries. They will be asked to fill in the diaries for 3 days after study visit1 and 3 days before study visit2. They will also receive a food frequency questionnaire during visit1. The second study visit will run nearly identical to study visit1 (except for food frequency questionnaire which will be omitted). During this visit, participants will receive information sheets on physical activity and dietary recommendations. The third and last visit will run nearly identically to the study visit2, except that no new glucose sensor will be inserted and also stool samples will not be collected.

NCT ID: NCT06159543 Not yet recruiting - Inflammation Clinical Trials

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM and VCAM? - What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: - Consume 1.5 cups of mango per day for 12 weeks, take a 4 week break, and then avoid consuming mangos for 12 weeks - Attend a prerandomization clinic prior to study - Attend three (3) clinics where blood will be drawn during weeks 0, 12, and 28 of the study - Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12, 16, 20, 24, and 28 of the study - Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

NCT ID: NCT06126354 Not yet recruiting - Insulin Resistance Clinical Trials

Dexamethasone/Pancreatic Clamp P&F

Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study in the setting of dexamethasone-induced insulin resistance. The investigators will recruit participants with a history of overweight/obesity but no history of prediabetes or diabetes. Participants will be rendered temporarily insulin resistant by taking seven doses of dexamethasone. They will then undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.

NCT ID: NCT06118931 Not yet recruiting - Obesity Clinical Trials

Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control

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

This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.

NCT ID: NCT06117358 Not yet recruiting - Pre-Diabetes Clinical Trials

Detection of Pre-Diabetes in Overweight and Obese Children

Start date: November 15, 2023
Phase:
Study type: Observational

Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.

NCT ID: NCT06064669 Not yet recruiting - Prediabetes Clinical Trials

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

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

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.

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