Active clinical trials for "Prediabetic State"

This study aims to determine whether the effectiveness of cinnamon spice capsules vs. placebo capsules on glucose tolerance in prediabetic subjects who are overweight or obese.

This study will test the weight loss efficacy of a mobile diabetes prevention program intervention. Half of the sample of prediabetic adults will receive the virtual DPP and half will receive usual medical care.

The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Prediabetics will be randomized to receive EFT/ERT in a factorial design when experiencing simulated poverty/neutral conditions, respectively. The effects will be measured on DD. The investigators predict that poverty conditions will increase discounting of the future for ERT subjects, but those receiving EFT will show levels of DD similar to levels observed for participants in the wealth condition.

Impaired fasting glucose (IFG), a significant risk factor for diabetes mellitus (DM), is commonly encountered in the primary care setting and represents an important target for DM prevention. However, data on the long term risk of progression from IFG to DM among Chinese subjects and associated risk factors are currently lacking; appropriate DM prevention programme for this group cannot be yet established. This is a prospective cohort study that aims to estimate the incidence of progression to diabetes mellitus (DM) among Chinese primary care patients with impaired fasting glucose (IFG) over a 3-year period and evaluate putative risk factors. A prospective cohort of around 700 non-diabetic Chinese adults who had IFG (i.e. fasting glucose level between 5.6 to 6.9mmol/L) and received baseline assessment between May 2013 and March 2015 at 3 public primary care clinics across Hong Kong will be invited for a 36-month-follow-up glycaemic status assessment (i.e. to repeat 75-gram oral glucose tolerance test (OGTT) and HbA1c test). The OGTT results will be used as the gold standard for the diagnosis of DM, normoglycaemia, IFG and impaired glucose tolerance (IGT) state. Demographics and lifestyle of the subjects including age, gender, occupation, education level, socio-economic status, smoking and drinking history, diet, exercise, work-sleep pattern, stress, quality of life and family history will be collected using standardized questionnaire. Participant's medical history and drug history will be retrieved from the Clinical Management System (CMS) of the Hospital Authority. Lipid profile, blood pressure, waist circumference and body mass index will also be assessed. Logistic regression model will be performed to determine if these variables are associated with progression from IFG to DM. The primary outcome is the incidence of DM among the IFG study population. The secondary outcomes are the risks of developing DM among subjects with isolated IFG or combined IFG/IGT and determinants of progression to DM. Knowledge on the natural history of isolated IFG or combined IFG/IGT among Hong Kong Chinese primary care patients and the significant modifiable associated risk factors for progression to DM will enable primary care researchers to design optimal management programme for diabetes prevention among these high risk patients.

The high prevalence of diabetes and prediabetes has increased the demand for nonnutritive sweeteners in recent years. Miracle fruit has been considered a healthy alternative sweetener for diabetic patients due to its sweetness-enhancing effects and high antioxidant activity. The purposes of this study are to examine whether the miracle fruit pill application to mouth prior to food consumption could improve the likings of different types of sour food (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and reduce energy intakes at the meals. Fifty volunteers (25 men and 25 women) aged 45 to 75 years with diabetes or prediabetes participate in the study. In this study, two interventions (miracle fruit and placebo) are provided, and all participants receive both applications. Participants are randomly assigned to one of the two interventions in part 1 and the assignment is switched from one application to another in part 2. The study hypotheses of this study are that the miracle fruit intervention improves the likings for sour foods and meals more than the placebo does; The miracle fruit intervention also reduces energy intakes from the meals more than the placebo does. Participants are asked to participate in a total of 6 sessions (1 hour/session, 1 session/day, Part 1: session 1, 2, & 3, Part 2: session 4, 5, & 6). Each session consists of two 30-min assessments, which are liking tests and meal intake assessment. The potential participants who have known food allergies or food intolerances are screened through consented screening procedure. If unknown food allergies or intolerances unintentionally become present during the study, medical help will be sought immediately. Participants may enjoy food samples and meals provided in this study and benefit by learning more about their acceptances for miracle fruit pill as an alternative sweetener. The results of this research are expected to develop generalizable knowledge about the miracle fruit's potential to improve the food palatability for people with diabetes or prediabetes.

The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control. In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.

The study will investigate the safety, feasibility, and efficacy of beta-alanine supplementation in adults with overweight or obesity. Beta-alanine is a widely used dietary supplement that can increase the amount of carnosine in skeletal muscle. Both carnosine and beta-alanine occur naturally in animal food products and previous research shows that supplementation with beta-alanine leads to an improvement in exercise performance; more recently, the present investigators have shown that increasing carnosine can also help to improve cardiometabolic health, detoxify skeletal muscle, and improve glucose (sugar) uptake into muscle cells. The investigators will recruit 30 participants (15 per arm) with overweight or obesity who meet the study criteria (this accounts for up to 20% attrition - a minimum of 12 participants per arm). Those who are eligible will be required to receive three short telephone calls and attend three laboratory sessions. Participants will be randomised to receive either beta-alanine or placebo (an inactive sugar pill) for the 3-month study period. To see whether beta-alanine supplementation is feasible in this population the investigators will measure recruitment, adherence (how well people can stick to the supplement regime), the number and nature of side effects, and blinding to the intervention. Markers of cardiac function, glycaemic control, and metabolic health will also be explored. All measurements will take place before and after a 3-month supplementation period. This will provide us with novel information of the role of beta-alanine and carnosine in cardiometabolic health; and will aid in the planning of a larger randomised controlled trial to assess the efficacy of beta-alanine supplementation as a therapeutic strategy.

Recently, various sodium glucose cotransporter 2 (SGLT2) inhibitors have been approved for the treatment of type 2 diabetes mellitus. Empagliflozin is a preparation of this class of substances. SGLT2 inhibitors also lead to a reduction in body weight in addition to their blood glucose lowering effect. The basis for this is probably the calorie loss by the increased glucose excretion over the urine. However, this weight-reducing effect is lost after a few weeks of treatment and the body weight subsequently stabilizes at a lower level than before. However, patients continue to lose energy via the urine. Hence, the weight stabilization could be due to an increased energy intake as a possible consequence of a changed brain setpoint for the body weight. As the main weight loss is achieved during the first 6-8 weeks of treatment, the investigators assume that the underlying central nervous mechanisms will be present after this time. Furthermore, clinical-experimental observations show that treatment with empagliflozin promotes endogenous glucose production in the liver. This presumably compensatory mechanism also occurs after only a few weeks of treatment. The common mechanism, which could be based both on energy intake and on the endogenous glucose production effect, is still unclear. The investigators suspect that regulatory circuits in the brain contribute to these observed effects. In fact, several studies in animals as well as initial clinical studies in humans show that the brain is involved in eating behavior and peripheral metabolism. In particular, effects of the hormone insulin modulate the dietary intake via the brain, thereby affecting human body weight. Many of the experiments on the insulin sensitivity of the human brain used a specific approach to the selective delivery of insulin into the brain: the application of insulin as a nasal spray. Although this application route has no therapeutic value, this technique allows the administration of insulin to the central nervous system with little effect on the circulating insulin levels. By combining nasal insulin administration with functional MRI, regional insulin sensitivity of the brain can be quantified. The investigators recently found that the insulin action of the brain (stimulated by nasal insulin) regulates both endogenous glucose production and peripheral glucose uptake during hyperinsulinemic euglycemic glucose clamps. The signals from the brain seem to reach the periphery via the autonomic nervous system in order to modulate metabolic processes. A central brain area in this regard is the hypothalamus. This brain region receives afferents over various systems such as the autonomic nervous system and various endocrine systems (including insulin). The investigators recently characterized the hypothalamus as an insulin-sensitive brain area in humans. The hypothalamus is the key area for homeostatic control throughout the body. Since the dietary intake and the endogenous glucose production are modulated by a hypothalamic insulin effect in humans, we suspect that the observed effects of SGLT2 inhibitors on both processes could be due to altered insulin activity in the brain. Since the SGLT2 inhibition by empagliflozin modulates the autonomic nervous system in the kidneys, signals from the kidney may be transmitted to the brain via the autonomic nervous system, thereby changing specific setpoints, including e.g. insulin sensitivity of the brain. In order to test this hypothesis, a precise phenotyping of prediabetic volunteers with regard to regional brain insulin sensitivity as well as the brain effect on metabolism before and after 8 weeks of treatment with empagliflozin compared to placebo is planned.

This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.

PREVENT-WIN study has three components. The work plan will have the following S&T components. Component 1: Cross-sectional Study Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure. Component 2: Prospective Study This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared. Component 3: Information Education and Communication (IEC) Activities: There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas. IEC material will be developed and IEC activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (Hindi and English) will be used for educating health professionals, Medical and paramedical workers and various village level health functionaries like, Multi purpose workers, anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and adverse health effects of vitamin D deficiency.