View clinical trials related to Prediabetic State.
Filter by:Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle. These abrupt changes often lead to a high prevalence of cardiometabolic diseases, such as impaired glucose tolerance/diabetes mellitus and dyslipidemia, conditions which predispose those with SCI to an increased risk for cardiovascular disease compared to the general population. Due to paralysis and wheel chair dependence, maintaining an adequate level of physical activity to counteract these deleterious metabolic changes presents a unique obstacle because conventional first line interventions are lifestyle modifications (e.g., diet and exercise), which may be difficult to achieve. Recently, a new medication has been approved by the Food and Drug Administration to improve glycemic control in individuals with diabetes mellitus, and it has also been investigated as an off-label treatment to induce weight loss. Glucagon-like peptide-1 (GLP-1) agonists are a class of drugs designed to mimic the endogenous incretin hormones released from the gut in a glucose dependent manner following a meal. The mechanisms of action for this drug class of medications include stimulation of glucose-dependent insulin secretion, inhibiting glucagon release, slowed gastric emptying, and reduction of postprandial glucose excursions following food intake. In addition to improved glycemic control, this class of medications also shows promise for its non-glycemic action of facilitating weight loss. The method of delivery of the GLP-1's is by self-administered injections once daily or once weekly, depending on the severity of the clinical case and therapeutic targets for a specific patient.
The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.
The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.
The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched groups including high intensity exercise, moderate intensity exercise, and non-exercise groups. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. The effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be evaluated.
Costa ES, Izar MC, Fonseca FAH, França C, Tria H. The benefits of green banana biomass consumption in patients with diabetes mellitus. Federal University of São Paulo, São Paulo, 2015. According to the Guidelines of the Brazilian Society of Diabetes, Diabetes Mellitus (DM) is a heterogeneous group of metabolic disorders associated with microvascular complications, hyperglycemia, resulting in a higher risk of developing cardiovascular disease. Currently, it is estimated that the world population with diabetes is 382 million people and it is expected to reach 471 million in 2035. About 80% of individuals with diabetes live in developing countries where the epidemic has greater intensity. In the Diabetes Control and Complications Trial and UK Prospective Diabetes Study demonstrated that intensive glycemic control (HbA1c ~ 7.0%) reduces chronic microvascular complications. The resistant starch (RS) is defined as starch and products of its hydrolysis are not absorbed in the small intestine. The green banana presents significant levels of RS, and it is considered a source for the intake of this substance. These foods have physiological functions in the intestinal regulation in glycemic control and delayed gastric emptying. To our knowledge, there are no long-term studies with DM to prove the benefits of resistant starch use. The objective of this study is to assess the benefits of green banana biomass consumption by patients with Pre DM and DM. Considering the possibility of improving glucose, lipid profile, increasing the secretion of glucagon-like peptide-1 (GLP-1), insulin, adiponectin, and reduction in inflammatory markers IL-6, PCR.
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.
The Personalized Nutrition Project for Prediabetes (PNP3) study will investigate whether personalized diet intervention will improve postprandial blood glucose levels and other metabolic health factors in individuals with prediabetes as compared with the standard low-fat diet.
Background: A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia. Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early intensive management of hyperglycaemia with linagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both). Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised, partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2 placebo tablets/day; 2) LSI + 2 Metformin tablets of 850 mg/day; 3) LSI + 1 Linagliptin tablets of 5 mg/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of Linagliptin 2.5mg and Metformin 850 /day. Active intervention will last for at least 2 years. Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 14 clinical centres from 10 countries: Australia, Austria, Bulgaria, Greece, Italy, Kuwait, Poland, Serbia, Spain and Turkey and . (N=1000) Main Outcomes: The primary endpoint is a combined continous variable: "the microvascular complication índex" (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after randomisation. In addition, serological biomarkers of inflammation, vascular damage, non-alcoholic fatty liver disease, insulin secretion, measures of quality of life, sleep quality, neuropsychological evaluation and endothelial function will be also evaluated in a subset of participants.
First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be evaluated. It is expected that metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin