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Glucose Intolerance clinical trials

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NCT ID: NCT06378125 Recruiting - Safety Issues Clinical Trials

Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes

Start date: December 19, 2022
Phase: Phase 1
Study type: Interventional

A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes.

NCT ID: NCT06377020 Recruiting - PreDiabetes Clinical Trials

Prevention and Choice for Type 2

PACT2
Start date: April 10, 2024
Phase: N/A
Study type: Interventional

People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2 , PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited.

NCT ID: NCT06366399 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Acute T-Rex (Timing of Resistance Exercise) Study

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur ~1.5 hours after habitual wake, and PM exercise will occur ~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus.

NCT ID: NCT06335225 Recruiting - Prediabetes Clinical Trials

Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics

Start date: March 13, 2024
Phase: N/A
Study type: Interventional

With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions.

NCT ID: NCT06330727 Recruiting - Prediabetes Clinical Trials

Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association.

NCT ID: NCT06319443 Recruiting - Glucose Intolerance Clinical Trials

Daily Vinegar Ingestion and 24-Hour Blood Glucose Control

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

When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7. Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant.

NCT ID: NCT06295913 Recruiting - Overweight Clinical Trials

Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases

HYTOLIVE15
Start date: March 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.

NCT ID: NCT06292000 Recruiting - Obesity Clinical Trials

Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes

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

Purpose of the Study: This study is to learn more about how exercising at different times of the day (morning versus evening) affects metabolism of glucose in the body, sleep, activity outside of exercise, and other factors. Procedures: - 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG). - If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks: - Baseline condition of NO exercise - Morning exercise for 3 days in a row - Evening exercise for 3 days in a row - You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a "traditional" diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time. - You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels. - You will undergo one x-ray scan to measure your level of body fat. - You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study. - You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study. - You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples). - You will be asked to complete a procedure called a "hyperinsulinemic-euglycemic clamp" where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study.

NCT ID: NCT06229795 Recruiting - PreDiabetes Clinical Trials

Effect of Green Tea on Obese Pediatrics With Prediabetes

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

The aim of this research is to evaluate the safety and efficacy of green tea in obese pediatrics with prediabetes versus the metformin therapy alone that is given to these patients. The primary outcome is to tackle the insulin resistance in these patients to prevent the deterioration of prediabetes to type 2 diabetes. The assessment of the effect on insulin resistance by using homeostatic model assessment for insulin resistance (HOMA-IR levels) as well as the effect on blood glucose levels and glycated hemoglobin. The other primary outcome is to observe the effect of the intervention on the lipid profile, leptin and adiponectin. The secondary outcome is to determine the effect of green tea on the oxidative and inflammatory markers and to evaluate its safety and efficacy. The study design is prospective parallel randomized open- label controlled interventional clinical trial that will be conducted in El-Demerdash hospital children's endocrinology unit. The patients who fit the inclusion criteria will be educated about the study protocol and will be required to sign a written informed consent. The inclusion criteria are: children whose age is between 10 to 18, whose HOMA-IR >2.5, BMI >= 95th percentile and have no sensitivity towards green tea and willing to sign informed consent. Patients who have causes of endogenous obesity will be excluded and those who have any other comorbid conditions. All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either Group 1 (Control group): Consists of 45 patients who will receive their conventional therapy which is Metformin 500 mg film coated tablets (Glucophage). Group 2 (Interventional group): Consists of 45 patients who will receive Green Tea 300 mg (Green tea 300 mg film coated tablets Mepaco Egypt) thrice daily + Metformin 500 mg film coated tablets (Glucophage). At baseline the following parameters will be collected during patients' interview and from patients' files: Demographic data as age, sex, weight and height (BMI), family history, medical history, medication history. Thyroid functions (TSH/T3): to rule out any other endocrine causes of obesity. Cortisol levels (am and pm): to rule out any other endocrine causes of obesity. The following laboratory' measurements will be tested at baseline and at the end of study (4 months): Complete Blood Picture, fasting blood glucose and postprandial blood glucose, fasting plasma insulin, homeostatic model assessment for insulin resistance, homeostatic model assessment for β-cell function, lipid profile, leptin, adiponectin, malondialdehyde, liver functions, kidney functions, c-reactive protein, nuclear factor kappa beta. Patients will be educated about the side effects and/or adverse effects of green tea, where safety and tolerability will be monitored by reporting the incidence of any side effect and /or adverse effect such as liver problems, yellowing of the color of skin or white of the eyes or stomach pain. Participants will be followed up during the study period every 2 weeks through clinic visits and by phone in order to assure compliance as well as monitoring of incidence of any side/adverse effects and informing the patients who to handle it.

NCT ID: NCT06188481 Recruiting - Pre-diabetes Clinical Trials

The Effect of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes

Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot study is to assess the feasibility of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes. The main goals and questions it aims to answer are: - Acceptability WB-EMS training in sedentary adults with pre-diabetes, - Has WB-EMS training positive effects on HbA1c and other biomarkers? Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.