View clinical trials related to Prediabetic State.
Filter by:The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defined as an excessive accumulation of lipids within hepatocytes in the absence of significant alcohol consumption or other causes of chronic liver disease. These patients usually present with hepatic steatosis observed on imaging studies and elevated liver enzymes with clinical features of insulin resistance (IR), including pre-diabetes, type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, and visceral obesity. The minimum criterion for a histologic diagnosis of NAFLD is >5 percent steatotic hepatocytes in a liver tissue section. The exact mechanism for the development of NAFLD is unclear, although the current evidence indicates that it is likely a complex interplay among neurohormones, intestinal dysbiosis, nutrition, and genetics. IR plays a crucial role in NAFLD pathophysiology mainly by increasing adipocyte lipolysis, resulting in the circulation of more free fatty acids available for hepatic uptake and increasing hepatic de novo lipogenesis. There is yet no approved pharmacologic option for the treatment of NAFLD. Current international guidelines on NAFLD emphasize the importance of lifestyle modifications for all patients with NAFLD and recommend 7-10% of weight loss and a "healthy diet", without suggesting any particular diet. Recent data provide some support for the beneficial role of low carbohydrate (CHO)/high unsaturated fatty acid (both monounsaturated (MUFAs) and polyunsaturated (PUFAs)) dietary patterns for decreasing hepatic steatosis. This proposal addresses this important research gap by leading to advances regarding the impact of a short-term low CHO/high PUFAs/MUFAs dietary intervention on improving hepatic gene expression profiles and lipid composition in individuals with pre-diabetes. The proposed study is unique because all meals and foods will be provided to participants under carefully controlled isocaloric conditions to maintain a constant bodyweight with optimal energy and macronutrient intake control. The primary objective of the proposed research is to investigate how replacement of dietary CHOs by unsaturated fatty acids (both PUFAs and MUFAs) affects liver fat composition and liver transcriptomics in subjects with pre-diabetes.
Although African traditional fermented foods have been linked to health benefits, research pertaining to the use of uniform products in the control of blood glucose is lacking. This study is aimed at assessing the effectiveness of African traditional fermented foods at reducing blood sugar amongst adult pre-diabetic patients. This study shall comprise a multi-centre parallel (3-arm) randomized controlled trial of a fermented milk product, a fermented cereal-based product, and standard medical care. 252 pre-diabetic adults shall be recruited from 12 treatment facilities located at 4 Counties (3 clinics from each County) across Kenya. The primary outcome is change in glycated haemoglobin. Secondary outcomes shall include, change in weight (BMI), waist circumference, levels of fasting plasma glucose, C reactive protein and lipid profile. Safety as well as the acceptability and experience of fermented foods as a treatment modality for pre-diabetes will additionally be assessed amongst study participants. At each study site, data comprising clinical measurements and responses from self-report questionnaires shall be collected over a follow-up period of 12 weeks. Two focus group discussions shall additionally be held in week 13. Comparison of the mean changes between the three groups shall be carried out using Analysis of Variance (ANOVA). Pairwise comparisons shall additionally be undertaken using linear mixed regression models.
The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations. The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD: - Increases the number of systematic examinations of sexual side effects, - Causes changes in the psycho-pharmacological treatment, and - Reduces the severity or perception of sexual side effects. The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions. The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.
To test these hypotheses, The Investigators will recruit 100 overweight and obese adolescents with HbA1c ranging across the ADA classification spectrum from normal to prediabetes,(nearly 40:normoglycemi, 30: IFG, 30:1GT) measure free-living glucose by continuous glucose monitoring (CGM), and assess the relationships among CGM outcomes, HbA1c, and OGTT results (FPG and 2-h glucose). Individual with overt diabetes will be excluded. This will be a 2 visit study. Subjects will be coming to Fortis CDOC after a minimum 8-hour overnight fast. Informed written consent and validated questionnaire in a language known to them (English/Hindi) will be obtained from all participants. Clinical details will be obtained from the case records of the patients. Note of visible markers of insulin resistance (acanthosis nigricans, buffalo hump, double chin, subcutaneous fat pads, skin) Anthropometry, skinfolds & blood pressure will be recorded. Overweight and, obesity will be defined according to predefined guidelines for Asian Indian. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females. A blinded iPro Continuous Glucose Monitor (Medtronic MiniMed, Inc) will be inserted. After a calibration period of 1 hour, fasting laboratory result will be collected: FPG, HbA1c. HbA1c will be done by HPLC (NGSP approved, turbid inhibition immunoassay). Then subjects will consume 1.75 g/kg glucose, maximum 75 g (glucose beverage) and will have a second venepuncture 2 hours later for plasma glucose measurement. While awaiting the 2-hour venepuncture, participants will be provided instructions on CGM device care and calibration. Participants will be instructed to wear the CGM device for a minimum of 72 hours and to not change any of their current dietary or activity habits for the period of CGM wear. They will be trained to use a glucose monitor and collect capillary blood glucose values at least three times daily, prior to meals. Participants will also be asked to complete a simple log of their activity, as well as record dietary intake, and sleep and wake times. The iPro and log-sheet will be returned in person after a minimum of 72 hours of recording time. Investigators and patients will be kept blinded to CGM recordings throughout the study. Daily glycaemic variability will be assessed by the change in the mean amplitude of glucose excursions (MAGE) index, and through the standard deviation (SD) of the mean 24-hour blood glucose concentration. Day-to-day variability will be assessed through the mean of daily differences (MoDD in mg/dL). Daily glycaemic control will be assessed by the mean (M) daily CGM value, as well as by the times (in minutes/day) spent in optimal glycaemic range (70-140 mg/dL) and above predefined hyperglycaemic thresholds (140 ,180 and 200 mg/dL) together with the corresponding area under the curve (AUC) values. In addition, areas under 24-hour glycaemic traces (AUCs) will be analysed to estimate: overall hyperglycaemia (defined asAUC≥100 mg/dL over the full 24-hour period = AUCtotal);postprandial hyperglycaemia (AUC[0-4 h], i.e. for four-hour periods after each of the main meals and, if considered relevant by the core laboratory, after additional snacks = AUCpp); and basal hyperglycaemia, i.e. overall hyperglycaemia - postprandial hyperglycaemia (AUCb)
The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
- Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.. - during the average 3 years of follow-up Prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;HbA1c, (5.7-6.4%) or plasma glucose level after an oral glucose tolerance test ( 140-199 mg/dl). - Reports estimate that more than 470 million people will have prediabetes by 2030. - According to an expert panel of the American Diabetes Association, up to 70% of individuals with prediabetes will eventually develop diabetes. - Observational evidence suggests as association between prediabetes and complications of diabetes such early nephropathy(10%) , small fiber neuropathy(18-25 %), early retinopathy (8-12%) and risk of macrovascular disease (52%) . - Screening for prediabetes is designed to save lives or enhance an individual's quality of life by early detection so that screening will minimize the risk of developing diabetes or its complications .
The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.
The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on glycemic control and weight in overweight and obese adults with Prediabetes or Type 2 Diabetes. The change in glycemic control from baseline at Days 90 and 180 following the G4LP and supplementation with Release will be assessed. Additionally, the safety and tolerability of the G4LP and Release supplementation will be measured by the occurrence of and/or changes in pre-emergent and post-emergent adverse events (AEs).