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Prediabetic State 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: NCT06354088 Recruiting - Insulin Resistance Clinical Trials

Human Models of Selective Insulin Resistance: Alpelisib, Part I

Start date: April 24, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day. The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.

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: NCT06330948 Recruiting - PreDiabetes Clinical Trials

Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation

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

Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement.

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: NCT06317142 Recruiting - Pre Diabetes Clinical Trials

Glucose and Glycogen Dynamics in Prediabetes

GGD
Start date: February 20, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate changes in nocturnal and postprandial glucose and glycogen metabolism in individuals with impaired fasting glucose and impaired glucose tolerance compared to healthy, non-diabetic, overweight participants (15 per group). In addition, it will be investigated if reducing gluconeogenesis, by using the challenge agent Acipimox, in people with prediabetes can increase glucose tolerance and fat oxidation by increased reliance on hepatic glycogen. The main questions this project aims to answer are: - whether there are differences in nocturnal glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls. - whether there are differences in postprandial glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls. Participants will visit the university for a screening visit and a visit with overnight stay for measurements of gluconeogenesis, glycogen, and substrate oxidation. A subgroup will receive [18F]-FDG to assess tissue-specific postprandial glucose uptake. Thereafter, 20 prediabetic individuals will follow a 4-day treatment with acipimox to decrease gluconeogenesis, followed by a second overnight visit with similar measurements as mentioned for the first visit.

NCT ID: NCT06296251 Recruiting - Dyslipidemias Clinical Trials

Dietary Supplementation on Body Fat Composition

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

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.