View clinical trials related to Prediabetes.
Filter by: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.
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.
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.
The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.
This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.
The goal of this study is to collect more information from people with plaque psoriasis and to determine if insulin plays a role in the pathogenesis of psoriasis. The main question it aims to answer is if insulin action is preserved or even enhanced in psoriatic lesions despite insulin resistance elsewhere. Participants with plaque psoriasis will have punch biopsies taken of lesional and non-lesional skin after an overnight fast and then during an oral glucose tolerance test. Biopsy specimens will then be assessed for markers of insulin action.
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.
Diabetes mellitus is a chronic metabolic disease associated with a high rate of disability and mortality. Prediabetes is the intermediate stage from normal blood glucose to diabetes. Reversal of prediabetes can help reduce the incidence of related complications and reduce premature mortality. Therefore, the early treatment of prediabetes is crucial, detection and effective management of this large population in time is the key to prevent diabetes. Overweight/obesity is one of the key risk factors leading to prediabetes and diabetes. In order to delay the progression of prediabetes and prevent related complications, weight loss is a key strategy to reverse prediabetes in overweight/obese patients. Lifestyle intervention is the first-line treatment for weight loss and is the most suitable intervention method. Although weight loss has been shown to have many metabolic benefits, it is a great challenge in the real world due to the long-term and complex of weight management. In order to further optimize the weight loss treatment of prediabetic patients, the study apply the mobile internet intelligent healthcare big data technology, 100 overweight/obese prediabetic patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1, with 50 patients in each group. The control group was treated according to the traditional diagnosis and treatment mode, and the diagnosis and treatment plan was formulated by the endocrinologist, and the diet education was conducted by the dietitian, and the individualized diet plan was formulated. Given a calorie-restricted diet, it is recommended to reduce daily energy intake by 500kcal on the basis of requirement. At least 150 minutes of moderate-intensity exercise per week is recommended. After the visit, the patient underwent follow-up self-weight monitoring and diet management outside the hospital. The intervention group was managed by co-management of three disciplines (endocrinologists, dietitians and weight managers). The three disciplines team tracked and assessed the patients' daily diet and weight changes, and gave guidance. The duration of intervention was 6 months. To explore the impact of the new model of mobile internet healthcare and "three disciplines co-management" on overweight/obese prediabetic patients, and whether it can improve the weight, glycemic and lipid metabolism and insulin resistance, and compare the reversal rate of prediabetes in the two groups.
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
Kuwait and the Gulf Region lack large longitudinal studies that identify risk factors dictating the onset of prediabetes and the progression to diabetes. The Kuwait Diabetes Epidemiology Program (KDEP), previously carried out at Dasman Diabetes Institute, was designed to develop a research dataset providing a random sampling of the Kuwaiti population. The dataset contained primarily epidemiology data for healthy, prediabetic and diabetic individuals; and was designed to serve as a resource for research and prevention programs on obesity, diabetes, and metabolic syndrome. The KDEP data supported research studies at DDI to delineate risk factors for metabolic disease from the views of genetics, biochemistry, immunology and epidemiology. One of the main limitations of the KDEP study was that it only captured a cross-sectional view of the participants in terms of diabetes status as well as lack of extensive phenotyping. In the current study, the investigators aim to perform a follow up on the non-diabetic KDEP cohort participants to enrich it with detailed physiological, genetic, biochemical and environmental data and thereby to establish an association between the development of diabetes and multidimensional risk factors. the investigatorswill also recruit family members of the KDEP and RA2010-005 participants as well as others with family history of diabetes to better identify familial patterns in risk factors. The outcome of this effort will immediately serve as a scientific baseline for developing prevention strategies for the control and management of obesity, diabetes and associated complications such as cardiovascular disease. Given the magnitude of the social and economic burden of diabetes on the Kuwaiti population, longitudinal data from the KDEP Follow-up study should play an important role in establishing the incidence of T2D progression in non-diabetic participants that were enrolled in the initial study as well as of progression to diabetes complications. This will have a positive impact on the population by providing clinicians with data to better target their patient management and by supporting policy and decision-makers in developing comprehensive health promotion programs to control these diseases at the national level.